Voies biliaires

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TITRE (EN) 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
CLINICAL TRIAL.gov ID NCT06109779
TYPE(S) DE CANCER Voies biliaires
PHASE Phase III
TYPE D'ÉTUDE Clinique
INSTITUTION CHU DE QUEBEC
1401 18e Rue
(418) 525-4444
VILLE Québec
INVESTIGATEUR(RICE) PRINCIPAL(E) Maxime Chénard-Poirier
COORDONATEUR(RICE) Alice Ndayizigiye
alice.ndayizigiye@chudequebec.ca
418-525-4444 poste 15782
STATUT  Actif en recrutement
CRITÈRES D'ÉLIGIBILITÉ (EN)
  • 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
CRITÈRES D'EXCLUSION (EN)
  • 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.