Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01)

Conditions de participation

• Sexe:

  ALL

• Âges admissibles:

  18 and up

Critères de participation

Inclusion 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.