Groupe d'Etude en Oncologie du Quebec

Title	A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Global Study of Rilvegostomig in Combination With Chemotherapy as Adjuvant Treatment After Resection of Biliary Tract Cancer With Curative Intent
Protocole ID	ARTEMIDE-Biliary01
ClinicalTrials.gov ID	NCT06109779
Cancer Type(s)	Hepatic Ducts
Phase	Phase III
Stage
Study Type	Clinical
Drug	Rilvegostomig + chimiothérapie au choix de l'investigateur versus placebo + chimiothérapie au choix de l'investigateur
Institution	CHU DE QUEBEC – UNIVERSITE LAVAL HOPITAL DE L'ENFANT-JESUS 1401 18e Rue, Québec, QC, G1J 1Z4
City
Principal Investigator	Dr. Maxime Chénard-Poirier
Coordinator	Alice Ndayizigiye 418-525-4444 poste 15782
Status	Recruiting
Activation Date	18-06-2024
Eligibility Criteria	Histologically confirmed adenocarcinoma of the biliary tract (intrahepatic or extrahepatic cholangiocarcinoma (CCA) or muscle invasive gallbladder cancer (GBC)) after macroscopically complete resection (R0 or R1) Provision of a tumor sample collected at surgical resection. Randomization within 12 weeks after resection with adequate healing and removal of drains. Confirmed to be disease-free by imaging within 28 days prior to randomization. Eastern Cooperative Oncology Group performance status of 0 or 1
Exclusion Criteria	Participants with locally-advanced, unresectable, or metastatic disease at initial diagnosis. Ampullary cancer, neuroendocrine, mixed neuroendocrine and non-neuroendocrine neoplasms and nonepithelial tumors. Any anti-cancer therapy for BTC prior to surgery 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 Thromboembolic event within 3 months Active HBV or HCV infection unless treated.

Groupe d'étude en oncologie du Québec