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Study on Durvalumab and Chemotherapy for Patients with Advanced Biliary Tract Cancer

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 the treatment of Advanced Biliary Tract Cancers, which are cancers that occur in the bile ducts, gallbladder, and the area where the bile duct meets the small intestine. The study will use a medication called Durvalumab, which is a type of drug that helps the immune system fight cancer. Durvalumab will be combined with a chemotherapy treatment that includes Gemcitabine, a drug that helps stop the growth of cancer cells. Other chemotherapy drugs that may be used in combination include Cisplatin, Oxaliplatin, Carboplatin, and Inflectra (infliximab). The purpose of the study is to assess the safety of using Durvalumab with Gemcitabine-based chemotherapy.

Participants in the study will receive the treatment through an infusion, which means the medication will be given directly into a vein. The study will follow a single-arm, open-label design, meaning all participants will receive the same treatment, and both the participants and the researchers will know what treatment is being given. The study will take place over several months, with regular check-ups to monitor the participants' health and the effects of the treatment. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of the actual treatment.

The study aims to gather information on how well the treatment works and any side effects that may occur. This information will help doctors understand the potential benefits and risks of using Durvalumab in combination with chemotherapy for treating advanced biliary tract cancers. Participants will be closely monitored throughout the study to ensure their safety and well-being. The study is expected to continue until 2026, with recruitment starting in 2024.

The research process

The trial runs in 6 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 participant will be informed about the trial's purpose and procedures. Consent will be obtained to ensure understanding and agreement to participate.

    Eligibility will be confirmed based on criteria such as age, medical condition, and previous treatments.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to evaluate the participant's health status. This includes medical history review and physical examination.

    Baseline measurements will be taken, including blood tests and imaging, to establish a starting point for the study.

  3. Step 3

    Treatment initiation

    The treatment phase begins with the administration of durvalumab in combination with gemcitabine-based chemotherapy.

    Durvalumab is given as an intravenous infusion. The frequency and dosage will be determined by the study protocol.

  4. Step 4

    Ongoing treatment and monitoring

    Participants will receive regular infusions of the study medications. The schedule will be outlined in the study protocol.

    Health status will be monitored through regular check-ups, blood tests, and imaging to assess the treatment's effects and any side effects.

  5. Step 5

    Safety and efficacy assessment

    The safety of the treatment will be evaluated by monitoring for any adverse effects. The study aims to assess the safety of combining durvalumab with chemotherapy.

    Efficacy will be measured by observing changes in the participant's condition, including tumor response and overall health.

  6. Step 6

    Completion of treatment

    Upon completion of the treatment phase, a final assessment will be conducted to evaluate the overall impact of the study medications.

    Participants will be informed about the results and any further steps or follow-up required.

Who can join the trial?

17 criteria

  • Participant must be 18 years or older, according to local regulations, at the time of screening.
  • Body weight must be more than 30 kg.
  • Both males and females can participate.
  • Women who can have children must have a negative pregnancy test.
  • Female participants must be one year post-menopausal, surgically sterile, or using a highly effective form of birth control. This means a method that is very reliable in preventing pregnancy. Women must agree to use this method from the start of the study until 90 days after the last dose of the study drug.
  • Male participants who are sexually active with a female partner who can have children must be surgically sterile or use a chosen method of birth control during the study and for 90 days after the last dose of the study drug. They must not donate sperm during this time. Female partners must also use a highly effective method of contraception.
  • Participant must be able to give signed informed consent, which means they understand and agree to the study's requirements and restrictions.
  • Written informed consent must be obtained from the participant before any study-related procedures.
  • Participants must provide signed consent for optional genomics research, which involves studying genes.
  • Participants must have a confirmed diagnosis of advanced or metastatic biliary tract cancer, which includes certain types of cancer in the bile ducts and gallbladder.
  • Participants with previously untreated disease are eligible if they have advanced or metastatic biliary tract cancer at the initial diagnosis.
  • Previous treatments aimed at curing the disease, like surgery or chemotherapy, are allowed, even if the disease has returned.
  • Participants must have a performance status of 0 to 2 on the WHO/ECOG scale, which measures how well they can perform daily activities.
  • Participants must have at least one measurable lesion, which is a tumor that can be measured on a scan.
  • Participants with hepatitis B virus (HBV) infection must be on antiviral therapy to control the virus before joining the study and continue it during the study and for 6 months after the last dose of the study drug.
  • Participants must have adequate organ and bone marrow function, which means their blood and organs are working well enough to handle the study treatment.
  • Participants must have a life expectancy of at least 12 weeks.

Who cannot join the trial?

8 criteria

  • Patients with other types of cancer besides Advanced Biliary Tract Cancers cannot participate.
  • Patients who are not within the specified age range cannot participate. The age range is typically defined by the study.
  • Patients who are not able to follow the study procedures or take the study medications cannot participate.
  • Patients with certain medical conditions that might interfere with the study cannot participate. These conditions are usually specified by the study.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have participated in another clinical trial recently may not be eligible.
  • Patients with allergies or reactions to the study medications cannot participate.
  • Patients with severe or uncontrolled health issues that could affect the study results cannot participate.
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Investigated drugs

  • Durvalumab

    is a medication used in this trial to help the immune system fight cancer cells. It is a type of immunotherapy that works by blocking a protein that stops the immune system from attacking cancer cells, allowing the immune system to better target and destroy them.

  • Gemcitabine-based Chemotherapy

    is a treatment that uses drugs to kill cancer cells or stop them from growing. In this trial, gemcitabine is used as a background therapy to support the main treatment with durvalumab. It is commonly used to treat various types of cancer, including biliary tract cancers.

What is already known about the treatment

Durvalumab – Durvalumab is administered as an intravenous infusion, typically in combination with chemotherapy. It is currently being studied in clinical trials for its effectiveness in treating advanced biliary tract cancers. The main therapeutic indication for durvalumab is to enhance the body's immune response against cancer cells. At the molecular level, it works by blocking a protein called PD-L1, which helps cancer cells evade the immune system. Durvalumab is classified as an immune checkpoint inhibitor, a type of immunotherapy.

Investigated diseases

Advanced Biliary Tract Cancers – This group of cancers originates in the bile ducts, gallbladder, or ampulla of Vater. These cancers are characterized by their location in the biliary system, which is responsible for transporting bile from the liver to the small intestine. As the disease progresses, it can cause symptoms such as jaundice, abdominal pain, and weight loss due to the obstruction of bile flow. The cancer may spread to nearby organs and tissues, complicating the condition further. Advanced stages indicate that the cancer has spread beyond its original site, making it more challenging to manage. The progression of these cancers can vary, but they often lead to significant health challenges due to their impact on liver function and bile flow.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502043-35-01Protocol codeD4191C00140Estimated enrolment216 patientsSponsorAstraZeneca AB

sourced from the EU Clinical Trials Register and site verification

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