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Study of Durvalumab and Tremelimumab with Y-90 SIRT Therapy for Patients with Advanced Intrahepatic Biliary Tract Cancer

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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 a type of cancer called advanced stage intrahepatic biliary tract cancer, which affects the bile ducts inside the liver. The study is exploring the effects of two medications, durvalumab and tremelimumab, which are types of immunotherapy. Immunotherapy is a treatment that helps the body's immune system fight cancer. In this study, patients will receive either durvalumab alone or a combination of durvalumab and tremelimumab. These medications are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

The purpose of the study is to assess how well these medications work in shrinking or controlling the cancer after patients have received a standard treatment called Y-90 SIRT therapy. Y-90 SIRT therapy is a procedure that uses tiny radioactive beads to target and treat cancer in the liver. The study will monitor the response of the cancer to the treatment, as well as the safety and any side effects experienced by the participants.

Participants in the study will receive the treatment over a period of time and will have regular follow-up visits to check on their health and the progress of the cancer. The study aims to provide valuable information on the effectiveness of combining immunotherapy with Y-90 SIRT therapy for treating advanced intrahepatic 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 have already provided fully-informed written consent and any necessary local authorizations.

    The patient must meet specific health criteria, including adequate liver function and a life expectancy of at least 12 weeks.

  2. Step 2

    Initial treatment: Y-90 SIRT therapy

    The patient will receive Y-90 SIRT therapy, which is a standard treatment for advanced intrahepatic biliary tract cancer.

    This therapy involves the use of radioactive particles to target cancer cells in the liver.

  3. Step 3

    Administration of durvalumab and tremelimumab

    Following the Y-90 SIRT therapy, the patient will receive immunotherapy with durvalumab and tremelimumab.

    Durvalumab is administered as a 50 mg/mL solution for infusion, and tremelimumab as a 20 mg/mL solution for infusion.

    Both medications are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, the patient's response to the treatment will be monitored regularly.

    This includes assessing the anti-tumor activity and checking for any side effects or adverse events.

    Scheduled follow-up visits and examinations will be conducted to ensure the patient's safety and to evaluate the effectiveness of the treatment.

  5. Step 5

    Study completion

    The study is expected to continue until December 31, 2026.

    Upon completion, the patient's overall response to the treatment will be evaluated, including the duration of response and overall survival.

Who can join the trial?

22 criteria

  • The patient must provide fully-informed written consent and any required local authorization before any study-related procedures are performed.
  • The patient must have adequate liver function, which includes:
    • Serum bilirubin (a substance made by the liver) should be no more than 1.5 times the normal limit.
    • AST (a liver enzyme) and ALT (another liver enzyme) should be no more than 2.5 times the normal limit, unless there are liver metastases, in which case they should be no more than 5 times the normal limit.
    • Prothrombin time (a blood test that measures how long it takes blood to clot) should be at least 60%.
    • Albumin (a protein made by the liver) should be at least 30 g/L.
    • Female patients who can have children must have a negative pregnancy test within 7 days before starting the trial.
    • Female patients must show evidence of being post-menopausal or have a negative pregnancy test if they are pre-menopausal. Post-menopausal status is defined by specific criteria related to age and medical history.
    • The patient must be willing and able to follow the study protocol, including attending hospital visits and follow-up examinations.
    • The patient must have a life expectancy of at least 12 weeks.
    • If the patient has Hepatitis B or C, they must meet specific criteria for monitoring and treatment during the study.
    • The patient must be at least 18 years old.
    • The patient must have a confirmed diagnosis of advanced or limited metastatic intrahepatic biliary tract cancer that cannot be treated with surgery or other curative methods. The cancer should be confined to the liver or have stable and limited spread outside the liver.
    • Patients who have had prior chemotherapy or immunotherapy can participate if they meet certain conditions related to their previous treatments.
    • The patient must be considered a candidate for standard Y-90 SIRT therapy, a type of radiation treatment, and not have any conditions that would prevent this treatment.
    • The patient must have a performance status of 0 or 1 on the ECOG scale, which measures the patient's ability to perform daily activities.
    • The patient must weigh more than 30 kg.
    • The patient must have at least one measurable site of disease according to specific criteria.
    • The patient must have adequate bone marrow and kidney function, which includes:
      • Hemoglobin (a protein in red blood cells) should be at least 9.0 g/dL.
      • Absolute neutrophil count (a type of white blood cell) should be at least 1.5 x 103/L.
      • Platelets (cells that help with blood clotting) should be at least 100 x 109/L.
      • Creatinine (a waste product filtered by the kidneys) should be no more than 1.5 times the normal limit.
      • Creatinine clearance (a measure of kidney function) should be at least 40 mL/min.

Who cannot join the trial?

10 criteria

  • Patients who have had another type of cancer in the past, unless it was a type that is not likely to come back.
  • Patients who have serious heart problems, like heart failure or a recent heart attack.
  • Patients who have serious lung problems, like severe asthma or chronic obstructive pulmonary disease (COPD).
  • Patients who have an active infection that needs treatment with antibiotics, antivirals, or antifungals.
  • Patients who have an autoimmune disease, which is when the body's defense system attacks its own cells.
  • Patients who are taking medications that suppress the immune system, which are drugs that lower the body's defense system.
  • Patients who have had an organ transplant, which is when a person receives a new organ from another person.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a known allergy to the study drugs or their ingredients.
  • Patients who have any other medical condition that the study doctors think would make it unsafe for them to participate.
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Investigated drugs

  • Durvalumab

    is a type of immunotherapy used in this trial. It helps the body's immune system to detect and fight cancer cells more effectively. In this study, it is being tested to see how well it works in treating advanced intrahepatic biliary tract cancer when used after a standard treatment called Y-90 SIRT therapy.

  • Tremelimumab

    is another immunotherapy drug used in combination with durvalumab in this trial. It works by enhancing the immune system's ability to attack cancer cells. The study aims to determine if the combination of tremelimumab and durvalumab is more effective than durvalumab alone in treating this type of cancer.

  • Y-90 SIRT Therapy

    is a standard treatment for patients with advanced intrahepatic biliary tract cancer. It involves using tiny radioactive beads to deliver radiation directly to the tumor, helping to shrink it and slow its growth. This therapy is used before administering the immunotherapy drugs in the trial.

What is already known about the treatment

  • Durvalumab

    Durvalumab is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating advanced intrahepatic biliary tract cancer. It is an immunotherapy drug that works by blocking a protein called PD-L1, which helps the immune system recognize and attack cancer cells. Durvalumab is classified as a monoclonal antibody and is being evaluated for its potential to improve the objective response rate in patients receiving standard Y-90 SIRT therapy.

  • Tremelimumab

    Tremelimumab is also administered intravenously and is under investigation in combination with durvalumab for treating advanced intrahepatic biliary tract cancer. It functions by targeting the CTLA-4 protein, enhancing the immune system's ability to fight cancer. As a monoclonal antibody, tremelimumab is being tested to determine its effectiveness in increasing the objective response rate when used alongside standard Y-90 SIRT therapy.

Investigated diseases

Intrahepatic Biliary Tract Cancer – This is a type of cancer that occurs in the bile ducts within the liver. It is characterized by the abnormal growth of cells in the bile ducts, which can lead to blockages and interfere with the normal flow of bile. As the disease progresses, it can cause symptoms such as jaundice, abdominal pain, and weight loss. The cancer is often diagnosed at an advanced stage because early symptoms are not specific. It can spread to nearby tissues and organs, making it challenging to treat. The progression of the disease can vary, but it typically involves the gradual worsening of symptoms and increased difficulty in managing the condition.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508314-42-00Protocol codeIMMUWHYEstimated enrolment50 patientsSponsorFrankfurter Institut Fuer Klinische Krebsforschung IKF GmbH

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