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PEHRICCA : PErioperative CISGEM plus RILVEGOSTOMIG in High-Risk resectable Intrahepatic CholangioCarcinoma
EU CTIS ID: 2025-521302-17-00
What this study is testing
Progression-free survival at 12 months
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 years
- Life expectancy ≥ 3 months
- Female Patients 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
You likely can't join if
- Existence of metastases or distant lymph node involvement considered as metastatic
- 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
See the full eligibility criteria
Who can join
- Age ≥ 18 years
- Life expectancy ≥ 3 months
- Female Patients 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 PS 0-1
- Body weight > 30kg
- Histo/cytologically proven intrahepatic cholangiocarcinoma
- Measurable disease as defined by Response Evaluation Criteria in Solid Tumors RECIST 1.1 criteria ».
- Naive to systemic treatment and loco regional treatment for biliary tract cancer
- Resectable disease with at least one of the following high-risk criteria of post resection relapse: • Tumor Size ≥ 50 mm and/or tumor number > ou = 3 nodules (maximum 5, in the same lobe), satellite nodules may be included ((intrahepatic metastases <2 cm at <2 cm from the primary nodule) • cN1 (according to TNM classification 8th edition 2017): hilar, peri duodenal and peri pancreatic adenopathy for iCCA of right liver and hilar, inferior phrenic, gastrohepatic, adenopathy for iCCA of left liver • Risk of R1 margin: distance < 10 mm from major structures, i.e., the right and left glissonian pedicles and/or hepatic veins (to be discussed during a MDT) • Macrovascular invasion (portal vein and/or sus hepatic veins and/or vena cava invasion). • ❖ (Liver MRI with PRIMOVIST contrast injection if possible, and diffusion-weighted sequences)
- 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) ≥ 1,500/μL • Platelets ≥ 150,000/μL
- Creatinine clearance ≥45 ml/min (calculated by CKD-EPI)
What rules you out
- Existence of metastases or distant lymph node involvement considered as metastatic
- 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
- Persons 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
- Locally advanced disease considered as definitively non resectable
- Cirrhosis with Child ≥ B7 a. Any history of liver decompensation: hepatic encephalopathy, presence of ascites b. 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 (>CTCAE grade 2) caused by previous cancer therapy, excluding alopecia.
- 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
- 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)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.