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Study of Durvalumab, Tremelimumab, and Capecitabine for Patients with Biliary Tract Cancer in an Adjuvant Setting

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying treatments for biliary tract cancer, a type of cancer that affects the bile ducts. The study is investigating the effectiveness of a combination of medications, including durvalumab (also known as MEDI4736), tremelimumab, and capecitabine. Durvalumab and tremelimumab are types of immunotherapy, which help the body's immune system fight cancer, while capecitabine is a chemotherapy drug that works by slowing or stopping the growth of cancer cells.

The purpose of this study is to assess how well these treatments work together in preventing the return of cancer after surgery. Participants in the study will receive either the combination of durvalumab and tremelimumab with capecitabine or without capecitabine. The study will monitor the participants over a period of time to see if the cancer comes back and to evaluate their overall survival and quality of life. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatments.

Throughout the study, participants will undergo regular check-ups and tests to monitor their health and the effects of the treatment. The study aims to gather information on the safety of the treatments and their impact on liver function, as well as to collect tissue and blood samples for future research. The study is expected to last until April 2025, with the goal of improving treatment options for patients with biliary tract cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will be required to provide written informed consent. This includes agreeing to participate in the study and any related research activities.

    The patient must have a confirmed diagnosis of biliary tract cancer that has been surgically removed without signs of spreading. The surgery should have occurred within the last 16 weeks.

  2. Step 2

    Initial assessment

    The patient will undergo a series of assessments to ensure they meet the study's eligibility criteria. This includes checking overall health, blood counts, liver and kidney function, and coagulation status.

    A performance status evaluation will be conducted to ensure the patient is physically able to participate in the study.

  3. Step 3

    Treatment phase

    The patient will receive a combination of medications: durvalumab and tremelimumab through intravenous (IV) infusion, and capecitabine taken orally.

    The specific dosage and frequency of these medications will be determined by the study protocol and the patient's individual health status.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, the patient will have regular visits to monitor their health and response to the treatment. This includes physical exams, blood tests, and imaging studies.

    The primary goal is to assess the recurrence-free survival rate at 12 months. Secondary goals include overall survival, safety, and quality of life assessments.

  5. Step 5

    End of study

    The study is expected to conclude by April 2025. At the end of the study, the patient's overall health and treatment outcomes will be evaluated.

    The patient may be asked to provide tissue and blood samples for future research to help identify potential biomarkers related to treatment outcomes.

Who can join the trial?

9 criteria

  • Must be able to give written permission to participate in the study, including any additional research if needed.
  • Must have a confirmed diagnosis of **biliary tract cancer** that has been surgically removed and is not spread to other parts of the body.
  • Must be 18 years or older.
  • Must have a **performance status** of 1 or less, which means being able to carry out daily activities without significant help.
  • Must have a life expectancy of at least 12 weeks.
  • Must have proper blood, liver, and kidney function. This includes having enough white blood cells, platelets, and hemoglobin, and normal levels of bilirubin, AST, ALT, and creatinine.
  • Must have normal blood clotting ability, unless on certain blood-thinning medications, in which case adjustments are needed.
  • If of reproductive age, must agree to use effective birth control during the study and for a period after the study ends. Women must have a negative pregnancy test before starting the study.
  • Must be willing and able to follow the study rules, including attending visits and undergoing tests and treatments.

Who cannot join the trial?

7 criteria

  • Patients who have a different type of cancer than biliary tract cancer cannot participate. Biliary tract cancer affects the tubes that carry bile, a fluid made by the liver, to the small intestine.
  • Patients who are not within the specified age range cannot participate. The age range for this study is not specified here, but it is important to be within the required age group.
  • Patients who are not able to follow the study procedures or who have conditions that make it unsafe for them to participate cannot join the study.
  • Patients who are pregnant or breastfeeding cannot participate, as the study may involve risks to the baby.
  • Patients who have participated in another clinical trial recently may not be eligible, as this could affect the study results.
  • Patients with certain medical conditions that could interfere with the study or make it unsafe for them to participate cannot join.
  • Patients who are unable to provide informed consent, which means they cannot understand the study and agree to participate, cannot join the study.
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Investigated drugs

  • Durvalumab

    is a type of immunotherapy that helps the body's immune system to detect and fight cancer cells. It works by blocking a specific protein that prevents the immune system from attacking cancer cells, allowing the immune system to target and destroy them more effectively.

  • Tremelimumab

    is another immunotherapy medication that enhances the immune system's ability to fight cancer. It works by targeting a protein that can suppress the immune response, thereby boosting the body's natural defenses against cancer cells.

  • Capecitabine

    is a chemotherapy medication that interferes with the growth of cancer cells. It is used to slow down or stop the growth of cancer cells by affecting their ability to divide and multiply. In this trial, it is being tested in combination with immunotherapy to see if it improves treatment outcomes for biliary tract cancer.

What is already known about the treatment

  • Durvalumab

    Durvalumab is administered as an intravenous infusion. It is currently being studied in clinical trials for its effectiveness in treating biliary tract cancer. The main therapeutic indication is to enhance the immune system's ability to fight cancer cells. At the molecular level, durvalumab works by blocking the PD-L1 protein, which helps cancer cells evade the immune system. It is classified as an immune checkpoint inhibitor.

  • Tremelimumab

    Tremelimumab is given through intravenous infusion. It is under investigation in clinical trials for its potential use in treating biliary tract cancer. The primary therapeutic indication is to stimulate the immune response against cancer cells. Its mechanism of action involves inhibiting the CTLA-4 protein, which can suppress the immune system's activity against tumors. Tremelimumab is also classified as an immune checkpoint inhibitor.

  • Capecitabine

    Capecitabine is taken orally in tablet form. It is being evaluated in clinical trials for its role in treating biliary tract cancer, often in combination with other drugs. The main therapeutic indication is to interfere with the growth of cancer cells. Capecitabine is converted into 5-fluorouracil in the body, which disrupts DNA synthesis in cancer cells. It is classified as an antimetabolite chemotherapy agent.

Investigated diseases

Biliary Tract Cancer – This is a type of cancer that occurs in the bile ducts, which are the tubes that carry bile from the liver to the gallbladder and small intestine. It can develop in different parts of the biliary system, including the intrahepatic, perihilar, and distal bile ducts. The disease often progresses slowly and may not show symptoms until it is advanced. As it progresses, it can cause symptoms such as jaundice, abdominal pain, and weight loss. The cancer can spread to nearby organs and tissues, making it more challenging to manage. Early detection is difficult, and the disease is often diagnosed at a later stage.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511847-24-00Protocol codeADJUBILEstimated enrolment40 patientsSponsorInstitut fuer Klinische Krebsforschung IKF GmbH

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