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

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What is this study about?

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.

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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centr Georges Francois Leclerc Dijon France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France
Oncopole Claudius Regaud Toulouse France
Aix Marseille University Marseille France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Centre Hospitalier De Colmar Colmar France
Hopital Saint Antoine Paris France
Centre Hospitalier Universitaire Rouen Rouen France
Hopitaux Universitaires Pitie Salpetriere Paris France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Centre Hospitalier De Perpignan Perpignan France
Centre Hospitalier Sud Francilien Corbeil Essonnes France
Hopital Prive Jean Mermoz Lyon France
Centre Hospitalier Universitaire De Montpellier Montpellier France
Centre Hospitalier De La Cote Basque Bayonne France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier De Boulogne Sur Mer Boulogne sur Mer France
Centre Hospitalier Universitaire De Caen Normandie Caen France
Centre Regional Lutte Contre Le Cancer STRASBOURG, Alsace France
L’Hopital Prive Du Confluent Nantes France
Strasbourg Oncologie Libérale – Clinique Sainte-Anne STRASBOURG, Alsace France
Chybiz Lald Bppoqs Lyon France
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Cjbvtf Hdqgbtnfkaa Ugvepclwruynm Dc Dcskz Dijon France
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
31.10.2025

Trial locations

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.

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 ID:
2025-521302-17-00
Protocol code:
PRODIGE 118-PEHRICCA
Trial Phase:
Therapeutic use (Phase IV)

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