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NOT YET RECRUITING
NCT07128290
PHASE2

PErioperative CISGEM + Rilvegostomig in High-Risk Resectable Intra Hepatic CholangioCarcinoma

Sponsor: Federation Francophone de Cancerologie Digestive

View on ClinicalTrials.gov

Summary

The goal of this trial is to determine whether the combination of CISGEM and Rilvegostomig during the perioperative period works to improve outcomes of patient undergoing surgery of high-risk of intrahepatic cholangiocarcinoma

Official title: PErioperative CISGEM + Rilvegostomig in High-Risk Resectable Intra Hepatic CholangioCarcinoma Phase II Single Arm Study - Multicenter

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

49

Start Date

2025-10-30

Completion Date

2029-04-30

Last Updated

2025-08-17

Healthy Volunteers

No

Interventions

DRUG

CISGEM + Rilvegostomig

Administration of 4 cycles pre-operative and 4 cycles post-operative of Cisplatine associated to Gemcitabine with rilvegostomig RILVEGOSTOMIG : For each cycle one administration at D1 every 3 weeks • 750 mg IV administration over 60 minutes (up to a total of 90 minutes). CISGEM: For each cycle administration at D1 and D8 every 3 weeks * Cisplatine 25 mg/m² in 1 hour IV in 1000 ml NaCl 0,9 % then 500 ml NaCl 0,9 % * Gemcitabine 1000 mg/m² en 30 mn IV dans 250 ml NaCl 0,9 %

Locations (9)

Chu Caen Normandie

Caen, France

Centre Gf Leclerc

Dijon, France

Chu de Dijon

Dijon, France

Chu Grenoble Alpes

Grenoble, France

Chu Dupuytren

Limoges, France

Hopital de La Timone Ap-Hm

Marseille, France

Nancy Chru

Nancy, France

Hopital Prive Du Confluent

Nantes, France

Chu de Poitiers

Poitiers, France