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PErioperative CISGEM + Rilvegostomig in High-Risk Resectable Intra Hepatic CholangioCarcinoma
Sponsor: Federation Francophone de Cancerologie Digestive
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
Conditions
Interventions
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