Treatment Options

Treatments are “interventions” – ie interfering with the current course or direction.

Cancer Treatment interventions fall into two categories.

  1. Drugs: Chemotherapy or Immunotherapy
  2. Physical: Surgery and or Radiation therapy
  • Surgery is the only potential cure for Cholangiocarcinoma, with less than 20% eligible for curative surgery. There is also a very high recurrence rate post-surgery.
  • Chemotherapy is the standard first-line drug treatment in Australia (& most countries.)
  • Immunotherapy is a recent and addition to the treatment toolkit and is making significant inroads to improving patient outcomes.
  • Please ensure that you are familiar with the “CCA Patient Toolkit” before reading the page content
Good resource for terminologies
Terms | Page | Treatment Options
  • Radiation therapy: (also called radiotherapy) is a cancer treatment that uses high doses of radiation to kill cancer cells and shrink tumors. At low doses, radiation is used in x-rays to see inside your body, as with x-rays of your teeth or broken bones.
  • Clinical Trials: There are many trials available or becoming available for Cholangiocarcinoma patients. Trials typically become an option after the “First Line” treatment options have failed. Trial entry is dependant on strict conditions, that your Biomarkers meet Immuohistochemical or Genomic compatibility conditions. Trials normally have no cost expense to the patient. A clinical trial is a study that compares responses to different interventions in real settings. Clinical trials are voluntary and are governed by strict rules and ethics.
  • Immunohistochemistry: (IHC) is a common application of immunostaining. It involves the process of selectively identifying proteins in cells of a tissue section. IHC takes its name from the roots “immuno” in reference to antibodies used in the procedure, and “histo” meaning tissue.
  • Immunohistochemical staining: is widely used in the diagnosis of abnormal cells such as those found in cancerous tumors. Specific molecular markers are characteristic of particular cellular events such as proliferation or cell death (apoptosis).
  • Genomic: Genomic testing is different from genetic testing because it looks at all of a person’s genes, rather than focusing on a specific gene, or set of genes. Genomic testing looks broadly for gene alterations, or harmful changes, anywhere in the genetic code.
  • Adjuvant Therapy: also known as adjunct therapy, add-on therapy, and adjuvant care, is therapy that is given in addition to the primary or initial therapy to maximise its effectiveness.
  • Inoperable: means surgeons deem the risk to the patient too great or metastasis has already occurred.
  • Metastasis: means the cancer has spread away from the “Primary” tumour location.
  • Primary: means the tumour location of origin.
  • Chemotherapy: Chemotherapy, often called ‘chemo’, uses medicines to destroy cancer cells. Chemotherapy is used on its own or in combination with other types of treatment. Chemo is mostly infused into your bloodstream and typically requires 3 to 6 month regimes which can be repeated several times.
  • Palliative Care:  Palliative care can begin at diagnosis, and at the same time as treatment.
  • Hospice Care: Hospice care begins after treatment of the disease is stopped and when it is clear that the person is not going to survive the illness.
  • Immunotherapy: Treatments that use the body’s immune system to fight cancer. This is done by boosting the patient’s own immune system or giving man-made versions of the immune system. See also immune system. View CCA’s  Immuno 101 for patients and caregivers.
Second Opinions are healthy
Making treatment decisions

After a cancer of the bile duct cancer is found and staged, you and your cancer care team will discuss treatment options. It is important that you understand the choices before you proceed. We strongly urge you to familiarise yourself with the CCA Patient Tool Kit, before committing to any post surgery treatment plans.

In choosing a treatment plan, there are some factors to consider:

  • The location and extent of the cancer.
  • Whether the cancer is resectable (removable by surgery).
  • The likely side effects of treatment.
  • Your overall health.
  • The chances of curing the disease, extending life, or relieving symptoms.
  • If time permits, it is often a good idea to seek a second opinion, particularly for an uncommon cancer like bile duct cancer. A second opinion can provide more
  • information empowers choice and decision making

Surgery, Radiation or Chemotherapy

Your Medical Team will guide you through these options.

  • Surgery is an option if the tumour is localised and not spread (Metastasised)
  • Chemotherapy and radiotherapy are typically given as adjuvant therapy soon after surgery to eradicate any unseen remaining cancer cells.
  • Surgery options are dependant on the tumour location
  • Surgery options:  Resection – the removal of the affected area a surrounding safety margin. Whipple -more invasive removing a much wider area (see Whipple under Surgery)
  • Stents: When symptoms are prevalent due to blockages in the bile duct, a stent can be placed to reinstate the flow. This is done by a small (same day) procedure called ECRP.
Surgery Overview
  • Surgery is a potential Curative intervention
  • Only a very small percentage qualify for surgery, as most diagnoses are late-stage and metastatic.
  • Successful Curative Surgery Outcomes are poor with most patients relapsing.

Due to the location and sensitivity of the bile duct area, surgery for cholangiocarcinoma can be very difficult. If the cancer is near the liver, part of the liver will be removed, along with the bile duct, gallbladder, and sometimes part of the pancreas and small intestine. If the cancer is near the pancreas, the surgeon may need to remove some or all of the pancreas and some small intestine. In order to maintain the appropriate flow of bile, the remaining part of the bile duct has to be connected to the small intestine. About 5% to 10% of people do not survive this complicated operation; others (25% to 45%) experienced serious complications, such as bleeding, infection, or leaking of bile or pancreatic juices. In some cases, surgeons cannot completely remove the tumor. Therefore, the surgeon bypasses the blocked area by connecting part of the bile duct before the blockage with a part of the small intestine beyond the blockage. The surgeon may insert a stent (a plastic or metal tube) into the bile duct to keep it open.

If the doctors think that the tumor cannot be removed by surgery, a plastic or metal stent can be passed through the blockage either during the ERCP procedure. Although these procedures do not remove the tumor, they relieve its effects and people often experience long periods of time when all of their symptoms disappear and quality of life is much better. The doctor will try to insert the stent internally, so the person will not be aware of its presence. Sometimes, this is not possible, and a tube will be passed through the liver to redirect the bile externally into a bag that will need regular changing. Some doctors suggest that in these situations people receive long-term antibiotics to guard against infection.


For resectable cancers, the type of operation depends on the location of the cancer.

Intrahepatic bile duct cancer: These cancers have started in bile ducts within the liver. To treat these cancers, the surgeon cuts out the part of the liver containing the cancer. Removing part of the liver is called a partial hepatectomy. Sometimes this means that a whole lobe of the liver must be removed. This is called hepatic lobectomy. It is a complicated operation and requires an experienced team of surgeons and assistants. If the amount of liver tissue removed is not too great, the liver will function normally because its tissue has some ability to grow back.

Perihilar bile duct cancer: These cancers begin where the branches of the bile duct first leave the liver. Surgery for these cancers requires great skill, as the operation is quite extensive. Usually part of the liver is removed, along with the bile duct, gallbladder, nearby lymph nodes, and sometimes part of the pancreas and small intestine. Then the surgeon connects the remaining ducts to the small intestine. This is not an easy operation for the patient, and about 8% die from surgical complications.

Distal bile duct cancer: These cancers are further down the bile duct near the pancreas and small intestine. Along with the bile duct and nearby lymph nodes, in most cases the surgeon must remove part of the pancreas and small intestine. This operation is called a Whipple procedure and like the other operations, this is a complex procedure that requires an experienced surgical team.

Possible risks and side effects: The risks and side effects of surgery depend in large part on the extent of the operation and a person’s general health. All surgery carries some risk, including the possibility of bleeding, infections, complications from anesthesia, pneumonia, and even death in rare cases.

People will have some pain from the incision for some time after the operation, but this can usually be controlled with medicines.

Surgery for bile duct cancer is a major operation that might mean removing parts of several organs. This can significantly affect a person’s recovery and health after the surgery. Because most of the organs are involved in digestion, eating and nutrition problems are often long-term side effects of surgery for this cancer.

Whipple Operation

A Whipple procedure is a complex operation to remove the head of the pancreas, the first part of the small intestine (duodenum), the gallbladder and the bile duct.

The Whipple procedure is used to treat tumors of the pancreas, intestine and bile duct. It is traditionally and most often used in surgery to treat pancreatic cancer that’s confined to the head of the pancreas. After performing the Whipple procedure, your surgeon reconnects the remaining organs to allow you to digest food normally after surgery.
The Whipple procedure is a difficult and demanding operation and can have serious risks. However, this surgery is often lifesaving, particularly for people with cancer.


In general surgery, a Roux-en-Y anastomosis, orRoux-en-Y, is an end-to-side surgical anastomosis of bowel used to reconstruct the gastrointestinal tract. Typically, it is between stomach and small bowel that is distal (or further down the gastrointestinal tract) from the cut end.


Palliative surgery
Palliative surgery may be performed to relieve symptoms or treat (or even prevent) complications, such as blockage of the bile ducts. This type of surgery is performed when the tumor is too widespread to be completely removed. Palliative surgery is not expected to cure the cancer, but it can sometimes help someone feel better and sometimes can even help them live longer.

In some cases, a doctor may think that cancer is resectable based on the information available (imaging tests, laparoscopy, etc.), but once surgery is started it becomes clear that the cancer is too advanced to be removed completely. At this point, the surgeon may do a biliary bypass to allow the bile to flow into the intestines to reduce symptoms such as jaundice or itching.

In this palliative procedure, the surgeon creates a bypass around the tumor blocking the bile duct by connecting part of the bile duct before the blockage with a part of the duct that lies past the blockage. Often, the gallbladder is used to provide some of the bypasses.

Video – Mayo Clinic

Liver Transplant

Unresectable Intrahepatic or Perihilar
Few livers are available for patients


The American Association for the Study of Liver disease Guidelines recommends that potential transplant candidates should be expeditiously referred to major cancer centers that have established protocols for oncologic assessment and treatment approved by United Network for Organ Sharing (UNOS).

Liver transplant: For some people with unresectable intrahepatic or perihilar bile duct cancers, removing the liver and bile ducts and then transplanting a donor liver may be an option. In some cases it might even cure the cancer.

But even for people who are eligible for a transplant, getting a new liver may not be easy. Not many centers accept patients with bile duct cancer into their transplant programs. Also, few livers are available for patients with cancer because they are generally used for more curable diseases. People needing a transplant must wait until a liver is available, which can take too long for some people with bile duct cancer. One option is having a living donor (often a close relative) give a part of their liver for transplant. This can be successful, but it carries risks for the donor.

Another option is to treat first with chemotherapy and radiation. This is followed by a transplant when a liver becomes available. This has been done as part of a clinical trial in the past, and may become a standard treatment for perihilar bile duct cancer.

Like other surgeries for bile duct cancer, a liver transplant is a major operation with potential risks (bleeding, infection, complications from anesthesia, etc.). But there are also some additional risks after this surgery.

People who get a liver transplant have to be given drugs to help suppress their immune system and prevent them from rejecting the new organ. These drugs have their own risks and side effects, especially the risk of getting serious infections. Some of the drugs used to prevent rejection can also cause high blood pressure, high cholesterol, and diabetes, can weaken the bones and kidneys, and can lead to the development of another cancer. After a liver transplant, regular blood tests are important to check for signs of rejection. Sometimes liver biopsies are also taken to see if rejection is occurring and if the anti-rejection medicines need to be changed.

More Information

Investigate further

Evaluation for Liver Transplantation in Adults Martin, P., DiMartini, A., Feng, S., Brown, R. and Fallon, M. (2014), Evaluation for liver transplantation in adults: 2013 practice guideline by the American Association for the Study of Liver Diseases and the American Society of Transplantation. Hepatology, 59: 1144–1165. doi: 10.1002/hep.26972


Minimally invasive
High dose of cancer-killing drug

Chemoembolization is a minimally invasive treatment for liver cancer that can be used when there is too much tumor to treat with radiofrequency ablation (RFA), when the tumor is in a location that cannot be treated with RFA, or in combination with RFA or other treatments.

Chemoembolization delivers a high dose of cancer-killing drug (chemotherapy) directly to the organ while depriving the tumor of its blood supply by blocking, or embolizing, the arteries feeding the tumor. Using imaging for guidance, the interventional radiologist threads a tiny catheter up the femoral artery in the groin into the blood vessels supplying the liver tumor. The embolic agents keep the chemotherapy drug in the tumor by blocking the flow to other areas of the body. This allows for a higher dose of chemotherapy drug to be used, because less of the drug is able to circulate to the healthy cells in the body. Chemoembolization usually involves a hospital stay of two to four days. Patients typically have lower than normal energy levels for about a month afterwards.

Chemoembolization is a palliative, not a curative, treatment. It can be extremely effective in treating primary liver cancers, especially when combined with other therapies. Chemoembolization has shown promising early results with some types of metastatic tumors. Although the individual materials used in this treatment are FDA approved, the treatment itself is not approved for intra-arterial therapy of liver tumors.


Similar to chemoembolization

Radioembolization is very similar to chemoembolization but with the use of radioactive microspheres. This therapy is used to treat both primary and metastatic liver tumors.

This treatment incorporates the radioactive isotope Yttrium-90 into the embolic spheres to deliver radiation directly to the tumor. Each sphere is about the size of five red blood cells in width. These beads are injected through a catheter from the groin into the liver artery supplying the tumor. The beads become lodged within the tumor vessels where they exert their local radiation that causes cell death. This technique allows for a higher, local dose of radiation to be used, without subjecting healthy tissue in the body to the radiation. The Yttrium-90 radiates from within and, since it is administered in the hepatic artery, it can be viewed as “internal” radiation.

Radioembolization is a palliative, not a curative, treatment-but patients benefit by extending their lives and improving their quality of life. It is a relatively new therapy that has been effective in treating primary and metastatic liver cancers. It is performed as an outpatient treatment. There are fewer side effects from this treatment compared to standard cancer treatments, with the main one being fatigue for seven to 10 days.


Treatment is easy on the patient

For inoperable liver tumors, radiofrequency ablation (RFA) offers a nonsurgical, localized treatment that kills the tumor cells with heat, while sparing the healthy liver tissue. Thus, this treatment is much easier on the patient than systemic therapy. Radiofrequency energy can be given without affecting the patient’s overall health and most people can resume their usual activities in a few days.

In this procedure, the interventional radiologist guides a small needle through the skin into the tumor. From the tip of the needle, radiofrequency energy (similar to microwaves) is transmitted to the tip of the needle, where it produces heat in the tissues. The dead tumor tissue shrinks and slowly forms a scar. The FDA has approved RFA for the treatment of liver tumors.

In a small number of cases, RFA can extend patients’ lives, but it is generally palliative. Depending on the size of the tumor, RFA can shrink or kill the tumor, extending the patient’s survival time and greatly improving their quality of life while living with cancer.

Because it is a local treatment that does not harm healthy tissue, the treatment can be repeated as often as needed to keep patients comfortable. It is a very safe procedure, with complication rates on the order of two to three percent, and has been available since the late 1990s.

By decreasing the size of a large mass, or treating new tumors in the liver as they arise, the pain and other debilitating symptoms caused by the tumors are relieved. While the tumors themselves may not be painful, when they press against nerves or interfere with vital organs, they can cause pain. RFA is effective for small to medium-sized tumors and emerging new technologies should allow the treatment of larger cancers in the future.

  • Is most effective when all the cancer is localized in the liver
  • Can be used to treat primary liver cancer and tumors that have metastasized (spread) from other areas in the body to the liver
  • Usually does not require general anesthesia
  • Is well tolerated – most patients can resume their normal routine the next day and may feel tired for a few days
  • Can be repeated if necessary
  • May be combined with other treatment options
  • Can relieve pain and suffering for many cancer patients


Directly into the tumor by a probe

Cryoablation is similar to RFA in that the energy is delivered directly into the tumor by a probe that is inserted through the skin. But rather than killing the tumor with heat, cryoablation uses an extremely cold gas to freeze it. This technique has been used for many years by surgeons in the operating room, but in the last few years, the needles have become small enough to be used by interventional radiologists through a small nick in the skin, without the need for an operation. The “ice ball” that is created around the needle grows in size and destroys the frozen tumor cells.

Treating the Pain

Controlling the Pain
Tumors refer Pain

Control of pain is one of the most important aspects of cancer care. Pain not only affects patients’ quality of life and ability to function, it may also lower their tolerance for needed cancer treatments.

In many cancer patients, pain results from the spread of the tumor into surrounding nerves and other tissues. For example, patients with cancer of the pancreas or stomach, sometimes experience pain from the spread of the tumor into a network of nerves and blood vessels in the abdomen called the celiac plexus. To treat the pain, interventional radiologists insert catheters or needles into the affected area and administer alcohol or other agents that destroy the nerves causing the pain.

A particularly painful complication of cancer is when the disease spreads (metastasizes) to bones. In a technique called transcatheter embolization, interventional radiologists inject tiny particles, the size of grains of sand, through a catheter and into the artery that supplies blood to the tumor. The particles cause clotting that decreases the tumors blood supply, reducing pain and decreasing the likelihood of bone fracture.

Controlling Bleeding

Clot the affected blood vessels
Hemorrhage or bleeding

If a cancer spreads to the blood vessels it may cause hemorrhage or bleeding. An interventional radiology technique called transcatheter embolization can be used to clot the affected blood vessels and stop the bleeding.

Treating Organs

Obstruction and Infection
Avoid Organ failure and infection

Cancers can obstruct the normal flow of urine or bile, causing these fluids to build up in the body. If left untreated, these conditions are not only painful but may also result in organ failure or infection. Under X-ray guidance, catheters can be inserted to drain the collection of fluids. Often, a small device called a stent is inserted into the organ to bypass the obstruction and allow fluids to drain internally.

Treating Blood Clots

Reduce Risk
Blood Clots can be life Threatening

One common side effect of cancer or cancer treatments is the development of blood clots, or emboli, that can be life-threatening if they travel to the brain, lungs or heart. There are two interventional radiology procedures that can reduce the risks posed by blood clots:

  • Intra-arterial thrombolysis. In this technique, the interventional radiologist guides a catheter through the blood vessels and to the site of a blood clot. Clot-busting drugs are infused through the catheter to break up the clot.
  • Filter placement. This technique is most often used when a blood clot is detected in the blood vessels of the leg (a condition called deep vein thrombosis). The interventional radiologist guides a small filter into the blood vessel that receives blood from the lower body (the vena cava) and carries it to the heart. If the blood clot dislodges from the vein in the leg, the filter will trap it before it can reach the heart.
Chemotherapy a Management tool
  • Chemotherapy is a management tool
  • Chemotherapy is not a curative treatment.
  • Primary objective to slow or stop progression
  • Some patients experience significant overall regression
  • Some Patients experience full elimination of visible cancer – NED (No Evidence of Disease)
  • Cholangiocarcinoma’s “First line” Chemotherapy Treatment is Gemcitabine and Cisplatin (Gem/Cis)
  • Typical First line treatment duration typically is 6 months
  • Treatment cycles 2 week on – 1 week off
  • Scans to measure treatment is 9 weekly or 12 Weekly dependant on aggression.
  • Gem/Cis is infused typically over 3 – 5 hours in a hospital Chemotherapy ward.
  • Variations: There are many more combinations including combining with Immunotherapy drugs. The basic idea behind this is for the chemotherapy agent to first do a general knock down to weaken all cells and then introduce the immunotherapy drug to have a great chance of success.

What is Chemotherapy

Infusion or Oral

Chemotherapy (chemo) is treatment with anti-cancer drugs that are given into a vein or by mouth. These drugs enter the bloodstream and reach all areas of the body, making this treatment useful in some cancers that have spread to organs beyond the bile duct. Because the drugs reach all the areas of the body, this is known as a systemic treatment.

Unfortunately, chemo has not been very effective against bile duct cancer, so its use has been somewhat limited. For resectable bile duct cancers (cancers that can be removed completely with surgery), chemo may be used after surgery (often along with radiation therapy) to try to lower the risk that the cancer will return. This is known as adjuvant chemo. Some doctors may use it before surgery for borderline resectable cancers to try to improve the odds that surgery will be successful. This is called neoadjuvant treatment. Chemo may also be used (sometimes with radiation therapy) for more advanced cancers. But it is not clear if chemo used in this situation helps people live longer. Doctors give chemo in cycles, with each period of treatment followed by a rest period to give the body time to recover. Chemo cycles generally last about 3 to 4 weeks. Chemo is often not recommended for patients in poor health, but advanced age by itself is not a barrier to getting chemotherapy.

Hepatic artery infusion:

Because of the poor response to regular (systemic) chemo, doctors have tried giving the drugs directly into the hepatic artery. This is known as hepatic artery infusion (HAI). The hepatic artery supplies blood to most bile duct tumors. The healthy liver can remove most of the remaining drug before it can reach the rest of the body. HAI may allow some people whose cancer was not removable by surgery to live longer, but more research is needed. This technique may not be useful in all cases because it often requires surgery to insert a catheter into the hepatic artery, an operation that many bile duct cancer patients might not tolerate well.

Bile Duct Drugs

Drugs used to treat bile duct cancer

Several drugs can be used to treat bile duct cancer. In some cases, 2 or more of these drugs may be combined to try to make them more effective. The drugs that have been used most often to treat bile duct cancer include:

  • 5-fluorouracil (5-FU)
  • Gemcitabine (Gemzar®)
  • Mitomycin C
  • Doxorubicin (Adriamycin®)
  • Cisplatin
  • Capecitabine (Xeloda)
  • Oxaliplatin

If you’d like more information on a drug used in your treatment or a specific drug mentioned in this section, see our Guide to Cancer Drugs, or call us with the names of the medicines you’re taking.

Side Effects

Effects vary with combinations

Chemo drugs work by attacking cells that are dividing quickly, which is why they work against cancer cells. But other cells in the body, such as those in the bone marrow, the lining of the mouth and intestines, and the hair follicles, also divide quickly. These cells are also likely to be affected by chemo, which can lead to side effects. The side effects of chemo depend on the type and dose of drugs given and the length of time they are taken. These side effects can include:

  • Hair loss
  • Mouth sores
  • Loss of appetite
  • Nausea and vomiting
  • Nerve damage (neuropathy), which can lead to trouble swallowing or numbness, tingling, and even pain in the hands and feet
  • Increased chance of infections (due to low white blood cell counts)
  • Easy bruising or bleeding (due to low blood platelet counts)
  • Fatigue (due to low red blood cell counts)

Radiation Therapy

Adjuvant Therapy
High-energy rays or particles

Radiation therapy is treatment with high-energy rays or particles that destroy cancer cells. The 2 main types of radiation therapy are external beam radiation and brachytherapy. These may be used in different settings to treat bile duct cancer:

After surgery for resectable cancers: This is known as adjuvant therapy. It is meant to kill any tiny deposits of cancer cells that remain after surgery (but are too small to see). Some doctors believe adjuvant radiation therapy is helpful, but more research is needed to confirm this.

As treatment before surgery for borderline resectable cancers: Some doctors may use radiation therapy before surgery for certain cancers that are thought to be resectable. This is done to try to shrink the cancer and make the operation easier and is known as neoadjuvant therapy. It’s not clear how helpful this is.

As part of the main therapy for some advanced cancers: Radiation therapy can also be used as a main therapy for some patients whose cancer has not spread widely throughout the body, but is not resectable. While treatment in this case does not offer a cure, it may help patients to live longer.

Radiation therapy may be given along with chemotherapy (chemo) to help it work better. This is called chemoradiation. Most often, the chemo drugs used are 5-fluorouracil (5-FU) or capecitabine (Xeloda®). The main drawback of this approach is that the side effects tend to be worse than giving radiation alone.

As palliative therapy: Radiation therapy is often used to palliate (relieve) symptoms when a patient’s cancer is too advanced to be cured. It may be used to relieve pain or other symptoms by shrinking tumors that block passageways for blood or bile, or press on nerves.

External Beam

Iradiation Therapy
Abbreviated to EBRT

This type of radiation therapy uses x-rays from a machine outside the patient’s body to kill cancer cells. It is the most common form of radiation therapy for bile duct cancer. The treatment is much like getting an x-ray, but the radiation is more intense. The procedure itself is painless. Before your treatments start, the radiation team will take careful measurements to determine the correct angles for aiming the radiation beams and the proper dose of radiation. Each treatment lasts only a few minutes, but the setup time — getting you into place for treatment — usually takes longer. Most often, radiation treatments are given 5 days a week for several weeks.

Standard (conventional) EBRT is used much less often than in the past. With newer techniques, doctors can more accurately treat bile duct cancers while reducing the radiation exposure to nearby healthy tissues. This may offer a better chance of increasing the success rate and reducing side effects.

Three-dimensional conformal radiation therapy (3D-CRT) uses special computers to precisely map the location of the tumor(s). Radiation beams are shaped and aimed at the tumor(s) from several directions, which makes it less likely to damage normal tissues. Most doctors now recommend using some form of 3D-CRT when it is available.

Intensity-modulated radiation therapy (IMRT) is an advanced form of 3D therapy. It uses a computer-driven machine that actually moves around the patient as it delivers radiation. In addition to shaping the beams and aiming them at the bile duct from several angles, the intensity (strength) of the beams can be adjusted to minimize the dose reaching the most sensitive normal tissues. This lets doctors deliver an even higher dose to the cancer areas. This procedure is available in many major hospitals and cancer centers.

Stereotactic body radiotherapy (SBRT) uses the techniques of 3D-CRT and IMRT, but gives the radiation over fewer sessions. A course of SBRT may take less than a week, while a course of radiation using these other techniques often takes place over 3 to 6 weeks.

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What is a clinical trial?

Cancer clinical trials are carefully designed research studies. A clinical trial aims to find out if a new treatment or procedure is safe and effective.

A clinical trial is a research study that tests different ways of improving people’s health. A clinical trial aims to find out if a new treatment or procedure is safe and effective. New drugs are first tested in the laboratory before being tested on people.

In cancer research, clinical trials can answer questions about how to:

  • prevent cancer, for example using diet, exercise or drugs
  • determine any genetic predisposition to cancer
  • detect cancer at an early and treatable stage, for example using screening blood tests, scans or other special tests
  • diagnose cancer, for example using blood tests, scans or new technologies
  • treat cancer, for example using surgery, drugs, and radiotherapy or different combinations of treatment
  • control symptoms of cancer or its treatment, for example using drugs and ‘complementary’ therapies such as diet, vitamins, exercise, yoga, meditation,
  • hypnotherapy or acupuncture.

Why are Clinical Trails Important ?

Clinical trials are an important way to improve treatment for people with cancer. Trials are the only reliable way that doctors and patients can find out the effects of different treatments. Trials tell us if a new treatment is more effective than the current standard treatment and they also identify risks and side effects. A new treatment will only become the new standard after it has been proved effective and safe in clinical trials, and shown to be better than other treatments.

The results of clinical trials today will help people with cancer in the future. Participating in a clinical trial may or may not be of direct benefit to you. Many of the effective treatments that are used today are the outcomes of studies in past years.

What are the different types Clinical Trails?

Treatment trials

Treatment trials are the most common type of cancer clinical trial. They test new treatments and/or compare them with standard treatments. The treatments tested include:

  • drugs – such as chemotherapy, hormones, antibiotics or targeted drugs
  • radiation therapy
  • surgery
  • other treatments, such as high dose treatment with bone marrow support
  • palliative care – treatment that helps the symptoms of cancer
  • counseling and psychological support
  • complementary and alternative therapies
  • ways to combine treatments

Screening trials

The aim of screening is to detect cancer before it has caused symptoms, with the hope of offering early treatment and improved health outcomes. A screening test often does not diagnose the cancer directly, but if the test is abnormal (positive) it suggests the person is more likely to have cancer than if the test is normal (negative). People with abnormal tests will go on to have more diagnostic tests and, if needed, appropriate treatment.

A screening trial may target either the general population, or a specific group at high risk of developing a particular cancer. Examples of screening include mammograms to detect early breast cancer, and faecal occult blood tests to detect early bowel cancer.

Prevention trials

Prevention trials involve people who do not have cancer. The trials look to see whether a particular intervention stops cancer from developing. Prevention trials might be carried out on the general population or on a group that it is at high risk of developing cancer. For some cancers the intervention tested might investigate a drug, a new diet, weight loss, exercise, quitting smoking or limiting alcohol.

Quality of life studies

A quality of life study looks at how the disease or treatment affects you. They are usually included as part of Phase 3 trials. Questionnaires are used to assess your quality of life. The type of questions that may be asked include whether you are more or less tired than usual, experiencing treatment related side effects, more or less anxious or depressed, how you are managing at home and at work and how you are feeling generally. It is important to know not only how a treatment affects the cancer but also how it makes you feel. This information can help inform others about the possible side effects of treatment.

What are the different phases of a Clinical Trail ?

Before a new treatment can become part of standard treatment it needs to go through a series of testing in what are called ‘phases‘. Following on from trials using animals, the main aim of early phase trials is to test if the treatment is safe for humans. Later phase trials investigate if the treatment is more effective than the currently available standard treatment. You may be asked to participate in any one of these phases of testing if you decide to take part in a clinical trial.

Phase 0 trials

Phase 0 trials are the first-in-human studies for drugs that have been previously tested in animals. Usually a single drug dose is given to 10-15 people to gather preliminary data on how the drug is metabolised and what effect the drug has on the body. The dose of drug given is below what is thought to have a therapeutic effect.   

Phase 1 trials

These are the first tests of a treatment in humans and involve approximately 15-30 people. They aim to see if the trial treatment is safe and to find the best dose. The research team notes major and minor side effects. This helps researchers to work out the best dose and the best way to give the trial treatment.

Phase 1 trials are usually only suitable for people with incurable cancer who have had all the known effective treatments for their cancer. People take part in these trials in the hope that the treatment may extend their life or improve their quality of life. Most often though, the reason to enter Phase 1 trials is to help people with cancer in the future.

If a Phase 1 trial shows that the new treatment is safe it will go on to Phase 2 testing.

Phase 2 trials

Phase 2 trials usually involve less than 100 people. The trials aim to see how well the new treatment works against cancer and to monitor for side effects.

Phase 2 trials generally involve people who have already had cancer treatment. The chance of the treatment being tested in a Phase 2 trial being effective depends on the type and extent of the cancer and its response to previous treatment.

If the new treatment shows promising effects (efficacy) against cancer and is safe then it is tested in Phase 3 trials.

Phase 3 trials

Phase 3 trials involve from hundreds to thousands of people. The trials are usually conducted through doctors’ offices, hospital clinics and cancer centres around the country or even around the world. They aim to test if the new treatment (the intervention treatment) is better than the current best standard treatment. They test treatments in real life settings, not the controlled circumstances under which Phase 1 and 2 trials are usually conducted.

Participants in Phase 3 trials are put in either the new treatment group or the standard treatment group at random. People in the trial are monitored carefully to see the effect of the treatment on the cancer, and on the length and quality of life.

If the new treatment works better, it may become the new standard treatment. In general, the new treatment needs to go through more than one Phase 3 trial for the treatment results to be accepted.

Phase 4 trials

‘Phase 4 trial’ refers to the long-term monitoring that sometimes occurs after a drug has been licensed for use and put on the market. Phase 4 trials are to assess any long-term side effects of a new treatment. There are very few Phase 4 trials.

What are randomised controlled clinical trials?

Randomised controlled trials are the best way to test if a new treatment is effective. In a randomised controlled trial people are allocated at random, using a process like a lottery, to receive the new treatment or a comparison or control treatment (usually the old treatment but sometimes a placebo). This random allocation of people to treatments ensures the groups (new treatment group and control treatment group) are as similar as possible.

It is important that any differences between the groups in the trial are due to the treatment, rather than the characteristics of the different groups. For example, one group of people could be older than the other at the start if groups were chosen by, say, location, and this might make the treatment results look better or worse, even if there was no real difference.

Randomisation is used in all Phase 3 trials and some Phase 2 trials. These trials are called ‘randomised controlled trials’ or ‘randomised clinical trials’. In these trials there are at least two different groups. One group, the ‘intervention’ group receives the treatment being tested and the other is the ‘control’ group. The control group gets the most widely-accepted current treatment, called the standard treatment. The people taking part in the trial are put into either one of these groups at random.

A computer is usually used for randomisation. Personal and medical details (such as age, gender and the extent of cancer) may be entered into the computer first. The computer gives each participant a code number. The code numbers are randomly allocated to the different treatment groups. The treatment arrives with a code number on it and is administered to the patient.

‘Blind’ trials

Ideally, neither the study staff nor the participants should be aware of the treatment anyone is receiving. This is called a ‘double-blind’ study. The reason for ‘blinding’ is that knowledge of the treatment might affect the way a person behaves during the trial. It can also affect the way study staff respond to participants in a trial and affect their assessment of patients’ symptoms and disease status.

‘Blinding’ occurs at different points in the trial, so that neither the researchers recruiting participants nor the person assessing the outcomes of the trial knows which treatment group the participant belongs to. This is so everyone is totally objective when evaluating response to the treatment, without being influenced by the treatment group that the person is in.

If only the participant is unaware of the treatment, it is called a ‘single-blind’ study.


A placebo is an inactive (or fake) treatment designed to look like the treatment being tested. Placebos are rarely used in cancer treatment trials. Occasionally a placebo will be used if there is no standard treatment for the control group to have. One group of people will receive the new treatment and another group will get the inactive treatment. Participants will not know which treatment they are getting ,so this will not unconsciously affect the results.

The ‘placebo effect’ is a term used to describe an improvement in the condition of participants who think they are being treated, but are in fact getting an inactive treatment.

In Brief
  • Immunology is a very fast developing option in treatment options, utilising the body’s immune system to defeat cancer.
  • Immunotherapy trials are being conducted on most Cancer genres and are also available as first-line treatments in some cancers.
  • Learn more on how Immunotherapy works
  • Most immunotherapy options are funded by the companies that host the trials.
  • Options exist to privately fund an immunotherapy treatment “Off Trial” if you do not directly qualify.
  • Australian Government / Treatment /Immunotherapy 
  • CCF Directory – Current Immunotherapy Trials
  • NIH Immunotherapy Page
  • Trials are running worldwide particularly in the USA, as well as Australia and NZ. It is important to remain globally aware of trial developments.
Video via CCF Conference 2016

Dr.Kate Kelly – talks about immunotherapy (19mins mark)

More information or help

Patient + Immunotherapy Mentor
Steve Holmes
Ph. +61415153522

Caregiver + Researcher Mentor

Claire Holmes
Claire +61431180783

Palliative Therapy

Palliative therapy is treatment given to help control or reduce symptoms caused by advanced cancer. It is not meant to be a curative treatment. If the cancer has spread too far to be completely removed by surgery, doctors may focus on palliative operations, palliative radiation, and other palliative therapies. Because these cancers tend to advance quickly, doctors try to use palliative therapies that are less likely to affect a person’s quality of life, when possible.

Biliary stent or biliary catheter

If cancer is blocking the bile duct, the doctor may insert a small tube (called a stent or catheter) into the duct to help keep it open. This may be done as part of a cholangiography procedure such as PTC or ERCP (see the section, “How is bile duct cancer diagnosed?”) or, in some cases, during surgery. A stent opens the duct to allow the bile to drain into the small intestine, while a catheter drains into a bag outside the body that can be emptied when needed. The stent or catheter may need to be replaced every few months if it becomes clogged and to reduce the risk of infection and gallbladder inflammation.

Biliary bypass

Another option to allow bile to reach the small intestine is to use a surgery called biliary bypass. There are several different biliary bypass operations, and the decision on which one to use is based on the location of the blockage. As mentioned in the “Surgery for bile duct cancer” section, this option is more likely to be used if a patient is already having surgery and the cancer turns out to be unresectable. While a bypass is clearly more invasive than placing a stent or catheter, it has some advantages in that the effects may last longer and infection is less likely to be a problem.

Palliative radiation therapy

Radiation therapy may be used to help relieve pain and other symptoms by killing some cancer cells that are causing blockage of the bile duct or are pressing on nerves.

Tumor ablation

Tumors in the liver that can’t be resected can sometimes be destroyed (ablated) by placing a long metal probe through the skin and into the tumor. The tip of the probe is then heated (in radiofrequency ablation) or frozen (in cryotherapy) to kill the cancer cells.

Photodynamic therapy (PDT)

For this technique, a light-activated drug is injected into a vein. A few days later, an endoscope (a long, flexible tube that can be used to look inside the body) is passed down the throat and into the bile duct. A special red light on the end of the endoscope is aimed at the tumor, causing the cells to die. The combination of PDT and stenting can help patients with bile duct cancer whose tumors aren’t resectable live longer.

Alcohol injection

To relieve pain, doctors may deaden the nerves that convey sensations of pain from the bile duct and intestinal area to the brain by injecting these nerves with alcohol. This can be done during surgery or later with the guidance of a CT.

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