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Study of cisplatin, gemcitabine and rilvegostomig treatment in patients with high-risk resectable intrahepatic cholangiocarcinoma

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 study focuses on patients with intrahepatic cholangiocarcinoma, a type of bile duct cancer that develops inside the liver and carries a high risk of returning after surgery. The treatment combines three medications: cisplatin and gemcitabine, which are standard chemotherapy drugs given through infusion, along with rilvegostomig, a new medication that works with the body's immune system to fight cancer cells.

The purpose of this research is to determine how well patients respond to treatment by measuring how long they remain free from cancer progression within 12 months. The treatment plan involves giving the combination of medications both before and after surgery. Before surgery, patients receive treatment through infusions. If suitable, they then undergo surgery to remove the cancer. After recovery from surgery, patients continue receiving the same combination of medications.

During the study, patients will receive regular medical examinations and imaging tests to monitor their response to treatment. The medications are given through intravenous infusion, which means they are delivered directly into the bloodstream through a vein. The total treatment period may last up to 18 months, during which patients will be closely monitored for any side effects or complications.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    You will receive pre-operative chemotherapy consisting of three medications: cisplatin, gemcitabine, and rilvegostomig. These medications will be given through an intravenous infusion.

    The treatment involves 4 cycles of chemotherapy before surgery.

    During this phase, your response to treatment will be monitored using imaging tests to evaluate the tumor according to RECIST 1.1 criteria (a standardized way to measure if tumors are responding to treatment).

  2. Step 2

    Surgery evaluation

    After completing the pre-operative chemotherapy, your medical team will evaluate if you can proceed with surgery.

    The goal is to remove the tumor from your liver with clear margins (area of healthy tissue around the tumor).

  3. Step 3

    Post-surgery treatment

    Following successful surgery, you will receive another 4 cycles of the same chemotherapy combination.

    The medications will again be administered through intravenous infusion.

  4. Step 4

    Follow-up period

    Your health will be monitored for at least 12 months after starting treatment.

    Regular check-ups will include medical examinations and imaging tests to check for any signs of cancer returning.

    You will be asked to complete quality of life questionnaires during the study to assess how the treatment affects your daily activities and well-being.

    Any side effects will be monitored and recorded according to standardized criteria.

Who can join the trial?

16 criteria

  • Must be at least 18 years old
  • Must have a life expectancy of at least 3 months
  • For women: must be postmenopausal for at least one year or surgically unable to have children for at least 6 weeks
  • Both men and women who can have children must use effective birth control during the study and for 7 months (women) or 4 months (men) after the last dose
  • Women who can become pregnant must have a negative pregnancy test
  • Must have health insurance coverage through the French Social Security system
  • Must provide written consent before any study procedures
  • Must have or be willing to provide a tissue sample from the tumor
  • Must have good physical performance status (WHO PS 0-1, meaning able to perform daily activities)
  • Must weigh more than 30 kg
  • Must have confirmed intrahepatic cholangiocarcinoma through tissue or cell examination
  • Must have measurable disease that can be evaluated using standard criteria
  • Must not have received any previous treatments for biliary tract cancer
  • Must have at least one high-risk feature: - Tumor size 50 mm or larger and/or multiple tumors - Affected lymph nodes - Risk of narrow surgical margins (less than 10mm) - Major blood vessel involvement
  • Must have adequate organ function, including: - Normal or slightly elevated liver enzymes - Normal or near-normal bilirubin levels - Good blood clotting function - Adequate albumin levels - Adequate blood cell counts
  • Must have adequate kidney function (creatinine clearance of 45 ml/min or higher)

Who cannot join the trial?

15 criteria

  • Patients younger than 18 years of age
  • Patients who have already received treatment for cholangiocarcinoma (cancer that forms in the bile ducts)
  • Patients with unresectable tumors (tumors that cannot be removed by surgery)
  • Pregnant or breastfeeding women
  • Patients with severe heart conditions
  • Patients with active infections
  • Patients participating in other clinical trials
  • Patients with known allergies to the study medications
  • Patients with significant liver dysfunction (poor liver function)
  • Patients with severe kidney problems
  • Patients with uncontrolled high blood pressure
  • Patients with active autoimmune diseases (conditions where the immune system attacks healthy cells)
  • Patients with history of other cancers in the past 5 years (except for adequately treated non-melanoma skin cancer)
  • Patients unable to follow study procedures or attend regular follow-up visits
  • Patients with psychiatric conditions that could interfere with the study compliance
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Investigated drugs

Based on the provided trial information: Cisgem is a chemotherapy medication used to treat bile duct cancer. It works by interfering with cancer cell growth and division, helping to slow or stop the spread of cancer cells. Rilvegostomig is a targeted therapy medication used in combination with chemotherapy for treating bile duct cancer. It is designed to help improve the effectiveness of cancer treatment, particularly in high-risk cases involving liver bile duct cancer. Note: These medications are used in a perioperative setting, which means they are administered around the time of surgery for bile duct cancer treatment.

What is already known about the treatment

  • Cisgem

    A chemotherapeutic agent administered intravenously in a hospital setting, primarily used in the treatment of intrahepatic cholangiocarcinoma (liver bile duct cancer). This medication belongs to the class of platinum-based antineoplastic drugs and works by binding to DNA, interfering with cell division and causing cancer cell death. It is currently being studied in clinical trials for perioperative treatment of high-risk resectable intrahepatic cholangiocarcinoma to improve patient outcomes.

  • Rilvegostomig

    An investigational targeted therapy medication being studied in combination with Cisgem for the treatment of intrahepatic cholangiocarcinoma. This drug is administered systemically and is designed to enhance the effectiveness of chemotherapy by targeting specific molecular pathways involved in cancer growth. It is currently being evaluated in clinical trials to assess its potential in improving progression-free survival in patients with resectable liver bile duct cancer.

Investigated diseases

Cholangiocarcinoma - A cancer that develops in the bile ducts, which are tubes that connect the liver to the gallbladder and small intestine. Intrahepatic cholangiocarcinoma specifically forms inside the liver, affecting the smaller bile ducts within the organ. The disease begins in the cells lining the bile ducts and can gradually grow to obstruct these channels. As the cancer develops, it can spread from its original location to nearby tissues and organs. The condition typically progresses slowly in its early stages, and symptoms may not be apparent until the disease has advanced.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2025-521302-17-00Protocol codePRODIGE 118-PEHRICCAEstimated enrolment49 patientsSponsorFondation Franc.Cancerologie Digestive

sourced from the EU Clinical Trials Register and site verification

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