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

NCT07128290 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2025-08-17

No results posted yet for this study

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

Conditions

  • Intrahepatic Cholangiocarcinoma (Icc)

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 %

Sponsors & Collaborators

  • Federation Francophone de Cancerologie Digestive

    lead OTHER

Principal Investigators

  • Gael ROTH, Dr · CHU DE GRENOBLES ALPES

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-30
Primary Completion
2029-04-30
Completion
2029-04-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07128290 on ClinicalTrials.gov