Not Yet RecruitingPhase 2

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

France49 participantsStarted 2025-10-30

Plain-language 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

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Age ≥ 18 years
✓. WHO Performance Status 0-1
✓. Body weight \> 30kg
✓. Histo/cytologically proven intrahepatic cholangiocarcinoma.
✓. Measurable disease as defined by RECIST 1.1 criteria (Response Evaluation Criteria in Solid Tumors).
✓. Naive to systemic treatment and loco regional treatment for biliary tract cancer
✓. At least one of the following high-risk criteria of post resection relapse:
✓. Adequate organ function, as defined by the following:

Exclusion criteria

✕. Existence of metastases or distant lymph node involvement considered as metastatic
✕. Locally advanced disease considered as definitively non resectable
✕. Cirrhosis with Child Pugh ≥ B7
✕. Any history of liver decompensation: hepatic encephalopathy, presence of ascites
✕. Presence of clinically significant portal hypertension (platelets counts \< 150G/L and/or liver stiffness \> 20kPa and/or presence of oesophageal and/or gastric varices)
✕

What they're measuring

Percentage of patients alive without progression at 12 months

Timeframe: 12 months after inclusion

Trial details

NCT IDNCT07128290

SponsorFederation Francophone de Cancerologie Digestive

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-04-30

Contact for this trial

Leathicia NDONG

+33 03 80 38 18 41 prodige118.pehricca@ffcd.fr

View on ClinicalTrials.gov More Intrahepatic Cholangiocarcinoma (Icc) trials