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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
49
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 %
Chu Caen Normandie
Caen, France
Centre Gf Leclerc
Dijon, France
Chu de Dijon
Dijon, France
Chu Grenoble Alpes
Grenoble, France
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.
Time frame: 12 months after inclusion
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.
Time frame: Up to 24 months after inclusion
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Chu Dupuytren
Limoges, France
Hopital de La Timone Ap-Hm
Marseille, France
Nancy Chru
Nancy, France
Hopital Prive Du Confluent
Nantes, France
Chu de Poitiers
Poitiers, France