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Study on Rilvegostomig and Chemotherapy for Patients with Biliary Tract Cancer After Surgery

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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 effects of a new treatment for biliary tract cancer, which includes types like intrahepatic or extrahepatic cholangiocarcinoma and muscle invasive gallbladder cancer. The treatment being tested is called rilvegostomig, also known by its code name AZD2936. It is a type of protein treatment given through an infusion, which means it is delivered directly into the bloodstream. The study will also involve the use of various chemotherapy drugs, including gemcitabine, capecitabine, cisplatin, and tegafur, which are commonly used to treat cancer. These drugs will be given either by infusion or orally, depending on the specific medication.

The purpose of this study is to determine if rilvegostomig, when combined with chemotherapy, is safe and effective in delaying the return of cancer after surgery. Participants in the study will be randomly assigned to receive either the new treatment combination or a placebo with chemotherapy. The study will be conducted in a double-blind manner, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This helps ensure the results are unbiased. The study will take place over several months, with regular check-ups and assessments to monitor the participants' health and the progression of the disease.

Throughout the study, the main focus will be on measuring how long participants remain free from cancer recurrence, known as recurrence-free survival. Other important aspects being evaluated include overall survival, which is the length of time participants live after treatment, and how well participants tolerate the treatment. The study aims to provide valuable information on whether rilvegostomig can be a beneficial addition to the current treatment options for 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 must have a confirmed diagnosis of adenocarcinoma of the biliary tract, which includes intrahepatic or extrahepatic cholangiocarcinoma or muscle invasive gallbladder cancer.

    The patient must have undergone a complete surgical resection of the tumor, with no visible cancer remaining.

    A tumor sample collected during surgery is required for study participation.

    The patient must be disease-free as confirmed by imaging within 28 days before randomization.

  2. Step 2

    Randomization

    Randomization occurs within 12 weeks after surgery, provided the patient has adequately healed and any surgical drains have been removed.

    The patient is assigned to one of two groups: one receiving rilvegostomig with chemotherapy, and the other receiving a placebo with chemotherapy.

  3. Step 3

    Treatment administration

    The treatment involves a combination of medications administered either intravenously or orally.

    Intravenous medications include sodium chloride, gemcitabine, cisplatin, rilvegostomig, and glucose.

    Oral medications include tegafur, capecitabine, infliximab, and mycophenolate mofetil.

    The specific dosage, frequency, and duration of each medication are determined by the study protocol and the patient's assigned group.

  4. Step 4

    Monitoring and follow-up

    The patient's health and response to treatment are regularly monitored throughout the study.

    Assessments include imaging tests to check for cancer recurrence and evaluations of overall health and treatment tolerability.

    The primary goal is to assess recurrence-free survival, with secondary goals including overall survival and progression-free survival after recurrence.

  5. Step 5

    Study completion

    The study is estimated to conclude by September 30, 2030.

    Upon completion, data from the study will be analyzed to determine the effectiveness and safety of rilvegostomig in combination with chemotherapy for patients with biliary tract cancer.

Who can join the trial?

8 criteria

  • The patient must have a type of cancer called adenocarcinoma of the biliary tract, which includes cancers in the bile ducts or gallbladder.
  • The cancer must be confirmed through a test called a histological examination, which looks at tissue under a microscope.
  • The patient must have had surgery to remove the cancer completely, which is known as macroscopically complete resection.
  • A sample of the tumor must be provided, which was collected during the surgery.
  • The patient must be able to start the study within 12 weeks after surgery, with proper healing and removal of any surgical drains.
  • The patient must be confirmed to be free of disease through imaging tests, like scans, within 28 days before starting the study.
  • The patient must have a good level of daily functioning, as measured by the Eastern Cooperative Oncology Group performance status, which should be 0 or 1. This means the patient is fully active or has some symptoms but can still carry out light work.
  • Both male and female patients can participate.

Who cannot join the trial?

8 criteria

  • Patients who have not had surgery to remove the cancer with the goal of curing it cannot participate.
  • Patients with other types of cancer, not related to the biliary tract, are excluded.
  • Patients who have serious health conditions that could interfere with the study are not eligible.
  • Patients who are pregnant or breastfeeding cannot take part in the study.
  • Patients who are unable to follow the study procedures or attend the required visits are excluded.
  • Patients who have participated in another clinical trial recently may not be eligible.
  • Patients with known allergies to the study drugs or similar medications cannot participate.
  • Patients who have had a recent infection or illness that could affect the study results are excluded.
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Investigated drugs

  • Rilvegostomig

    is an investigational medication being studied for its potential to improve outcomes in patients with biliary tract cancer. It is being tested in combination with chemotherapy to see if it can help prevent the cancer from returning after surgery. The goal is to determine if this combination is more effective than chemotherapy alone.

  • Chemotherapy

    refers to the use of drugs to destroy cancer cells. In this trial, chemotherapy is used alongside rilvegostomig to treat patients who have had surgery for biliary tract cancer. The aim is to eliminate any remaining cancer cells and reduce the risk of the cancer coming back.

What is already known about the treatment

Rilvegostomig – This medication is administered intravenously, typically in combination with chemotherapy, as part of a treatment regimen for patients who have undergone surgery for biliary tract cancer. It is currently being studied in clinical trials to assess its effectiveness in improving recurrence-free survival in these patients. Rilvegostomig is primarily indicated for use in cases of adenocarcinoma of the biliary tract, including intrahepatic or extrahepatic cholangiocarcinoma and muscle-invasive gallbladder cancer. At the molecular level, it works by targeting specific pathways involved in cancer cell growth and survival, although the exact mechanism is still under investigation. It is classified as an investigational cancer therapy, reflecting its ongoing evaluation in clinical research.

Investigated diseases

Adenocarcinoma of the biliary tract – This disease involves the formation of cancerous cells in the bile ducts, which can be located inside the liver (intrahepatic) or outside the liver (extrahepatic). It can also affect the gallbladder, leading to muscle-invasive gallbladder cancer. The disease typically begins with abnormal cell growth in the lining of the bile ducts or gallbladder, which can form tumors. As the disease progresses, these tumors may grow and spread to nearby tissues and organs. Symptoms often include jaundice, abdominal pain, and weight loss, but they may not appear until the disease is advanced. The progression of the disease can vary, with some cases remaining localized while others spread more aggressively.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506054-20-00Protocol codeD7025C00001Estimated enrolment750 patientsSponsorAstraZeneca AB

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