Intrahepatic Cholangiocarcinoma (Icc)Phase 2PEHRICCANCT07128290

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

A Phase 2 study testing CISGEM + Rilvegostomig in people with Intrahepatic Cholangiocarcinoma (Icc), run by Federation Francophone de Cancerologie Digestive at 9 sites in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Intrahepatic Cholangiocarcinoma (Icc)
What is being tested?: CISGEM + Rilvegostomig
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 49 participants
Where: 9 sitesFrance
Study dates: 30 Oct 2025to 30 Apr 2029
Phase: Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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
Serum albumin ≥ 30 g/L
Haemoglobin ≥ 10 g/dl and no transfusion within 4 weeks before inclusion
Absolute Neutrophil Count (ANC) ≥ 1.5 G/L
Platelets ≥ 150 G/L
Creatinine clearance ≥ 45 ml/min (calculated by CKD - EPI formula)
Life expectancy ≥ 3 months
Female postmenopausal for at least one year or surgically infertile for at least 6 weeks, or highly effective contraception for male and female patients of childbearing potential for the duration of study and for 7 months after the last dose of drug for female and 4 months for male.
A negative pregnancy test for inclusion for all female patients of child-bearing potential.
Patient covered by a plan of the French Social Security system.
Written informed consent obtained from the patient prior to performing any protocol-related procedures
Patient with available tumor tissue sample for the study or willing to have a biopsy

Who cannot join

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)

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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.
Uncontrolled infection with human immunodeficiency virus (HIV). Required conditions for inclusion are as follows: undetectable viral RNA, CD4+ count ≥350 cells/μL no history of AIDS-defining opportunistic infection within the past 12 months, stable condition for at least 4 weeks on the same anti-HIV medications.
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
Pregnant or breastfeeding woman.
Person deprived of liberty or under guardianship or incapable of giving consent
Inability to undergo the medical follow-up of the trial for geographical, social or psychological reasons.

Trial locations and contacts

9 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Leathicia NDONG contact

+33 03 80 38 18 41

prodige118.pehricca@ffcd.fr

City, postcode or hospital

9 sites in 1 country

France9 sites

Chu Caen Normandie
Caen
Anne-Laure BIGNON, Dr, + 33 02 31 06 54 37, bignon-al@chu-caen.fr
Centre Gf Leclerc
Dijon
François GHIRINGHELLI, Pr, +33 03 80 73 75 06, fghiringhelli@cgfl.fr
Chu de Dijon
Dijon
Sylvain MANFREDI, Pr, + 33 03 80 28 12 66, manfredi.sylvain@chu-dijon.fr
Chu Grenoble Alpes
Grenoble
Gael ROTH, Dr, + 3304 76 76 61 50, Groth@chu-grenoble.fr
Chu Dupuytren
Limoges
Frederic THUILLIER, Dr, + 33 05 55 08 72 92, frederic.thuillier@chu-limoges.fr
Hopital de La Timone Ap-Hm
Marseille
Laetitia DAHAN, Pr, + 33 04 91 38 85 16, laetitia.dahan-recherche@ap-hm.fr
Nancy Chru
Nancy, 54500
Marie MULLER, Dr, +33 07 70 18 79 79, m.muller7@chru-nancy.fr
Hopital Prive Du Confluent
Nantes
Hélène CASTANIE, Dr, + 33 02 28 27 21 89, helene.castanie@groupeconfluent.fr
Chu de Poitiers
Poitiers
Violaine RANDRIAN, Dr, + 33 05 49 44 34 98, violaine.randrian@chu-poitiers.fr

Other trials in France

About this study

Official title: PErioperative CISGEM + Rilvegostomig in High-Risk Resectable Intra Hepatic CholangioCarcinoma Phase II Single Arm Study - Multicenter

Conditions: Intrahepatic Cholangiocarcinoma (Icc)
Being tested: CISGEM + Rilvegostomig
Keywords: Perioperative, Rilvegostomig, CISGEM, High-risk resectable, intrahepatic cholangiocarcinoma
Medical subject headings: Cholangiocarcinoma, Cirrhosis, Familial, with Pulmonary Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CISGEM + RilvegostomigDrug
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 groups in NCT07128290
Study group	Role	What they receive
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 % Receives: Drug: CISGEM + Rilvegostomig

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 12 months after inclusion

Secondary outcomes (1)

Overall survival
Overall survival is defined as the time from the date of inclusion to the patient's death (all causes). For alive patients, the date of the last news will be taken into account.
Measured: Up to 24 months after inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Oct 202530 Apr 2029

First posted17 Aug 2025
Study start30 Oct 2025 (estimated)
Primary completion30 Apr 2029 (estimated)
Study completion30 Apr 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Intrahepatic Cholangiocarcinoma (Icc)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 49 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07128290
Sponsor's protocol ID: PRODIGE 118 - FFCD 2402
Other IDs: 2025-521302-17-00, 2025
Acronym: PEHRICCA
Status last verified: Aug 2025
First submitted: 13 Aug 2025
Last updated: 17 Aug 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided