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

Sponsor
Federation Francophone de Cancerologie Digestive
Study ID
NCT07128290
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Intrahepatic Cholangiocarcinoma (Icc)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CISGEM + Rilvegostomig — DRUG
    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 %

Study Details

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

Key Dates

Start date
Oct 30, 2025
Status verified
Aug 2025
Primary completion
Apr 30, 2029
Completion
Apr 30, 2029

Study Design

Enrollment
49 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CISGEM + 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 %

Primary Outcome Measure

Percentage of patients alive without progression at 12 months [ Time Frame: 12 months after inclusion ]

Central Contacts

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