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

NCT07128290 | Not Yet Recruiting Phase 2 DMC

• 2 other identifiers: PRODIGE 118 - FFCD 24022025-521302-17-00
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 9

Brief 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)

Keywords

Perioperative; Rilvegostomig; CISGEM; High-risk resectable; intrahepatic cholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

• Percentage of patients alive without progression at 12 months

  Progression was assessed by the investigator according to RECIST 1.1 criteria based on imaging studies performed every 9 weeks, Clinical progressions, not confirmed on imaging, were not be counted in the primary endpoint. Death for all causes is also an event.

  12 months after inclusion

Secondary Outcomes (1)

• Overall survival

  Up to 24 months after inclusion

Study Arms (1)

CISGEM + Rilvegostomig

EXPERIMENTAL

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 %

Drug: CISGEM + Rilvegostomig

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 %

CISGEM + Rilvegostomig

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Tumor Size ≥ 50 mm and/or multiple nodules
• cN+
• Risk of narrow margin (\< 10 mm)
• Macrovascular invasion
• Adequate organ function, as defined by the following:
• Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) ≤ 2,5 x Upper Limit of Normal (ULN)
• Total serum bilirubin ≤ 1.5 ULN This will not apply to patients with confirmed Gilbert's syndrome
• Prothrombin ratio \> 70 % and/or Factor V \> 70 % in case of oral anticoagulation therapy

You may not qualify if:

• 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)
• Mixed histology (hepatocholangiocarcinoma)
• Persistent toxicities (\> grade 2 NCI-CTCAE version 5.0) caused by previous cancer therapy.
• Contraindication to immunotherapy: Active or prior documented autoimmune or inflammatory disorders or any severe or uncontrolled systemic disease
• Current or prior use of immunosuppressive medication within 14 days before the first dose of protocol treatment
• History of allogenic organ transplantation
• Known or suspected allergy or hypersensitivity to any of the study drugs or any of the study drug excipients (cisplatin, gemcitabine and Rilvegostomig)
• Live vaccine administration within 30 days prior to the first dose of study treatment Note: Patients, if enrolled, should not receive live vaccine whilst receiving investigational product and up to 6 months after the last dose of investigational product.
• Active and untreated infection with hepatitis B and/or hepatitis C Note: Patients with past HBV infection or resolved HBV infection (defined as having a negative HBsAg test and a positive hepatitis B core antigen \[HBc\] antibody test) are eligible.
• Other active cancer or history of cancer within 2 years, except for carcinoma in situ of the cervix or basal cell or squamous cell skin carcinoma or any other carcinoma in situ, considered cured
• History of clinically significant arrhythmia, cardiomyopathy of any etiology; symptomatic congestive heart failure (as defined by New York Heart Association class ≥ 3), history of myocardial infarction within the past 6 months. Participation in another clinical study with an investigational product during the last 4 weeks

Sponsors & Collaborators

• Federation Francophone de Cancerologie Digestive: lead

Study Sites (9)

Chu Caen Normandie

Caen, France

Location

Centre Gf Leclerc

Dijon, France

Location

Chu de Dijon

Dijon, France

Location

Chu Grenoble Alpes

Grenoble, France

Location

Chu Dupuytren

Limoges, France

Location

Hopital de La Timone Ap-Hm

Marseille, France

Location

Nancy Chru

Nancy, 54500, France

Location

Hopital Prive Du Confluent

Nantes, France

Location

Chu de Poitiers

Poitiers, France

Location

MeSH Terms

Conditions

Cholangiocarcinoma; Cirrhosis, Familial, with Pulmonary Hypertension

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Gael ROTH, Dr

  CHU DE GRENOBLES ALPES

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leathicia NDONG

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: August 17, 2025
• Study Start: October 30, 2025
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): April 30, 2029
• Last Updated: August 17, 2025

Record last verified: 2025-08

Locations

FR (9)