Brief Summary
A global study to assess the efficacy and tolerability of rilvegostomig compared to placebo in combination with investigator’s choice of chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells in participants with BTC after surgical resectionsurgical removal of tissue or part/all of an organ with curative intent.
Intervention / Treatment
- Drug: Rilvegostomig
- Drug: Placebo
- Drug: Capecitabine
- Drug: Gemcitabine/Cisplatin
- Drug: S-1 [Tegafur/Oteracil/gimeracil]
Inclusion Criteria:
- Histologically confirmed adenocarcinomacancer arising from mucus-producing glands in organs of the biliary tract (intrahepatic or extrahepatic cholangiocarcinoma (CCA) or muscle invasive gallbladder cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs (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 imagingtests that create detailed images of areas inside the body within 28 days prior to randomization.
- Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group performance status of 0 or 1.