Epidemiological study of gall bladder cancer

Abstract

qd) þ atezolizumab (1200 mg infusion q3w), a control arm of sorafenib (400 mg bid), and an exploratory arm of cabozantinib monotherapy (60 mg qd). 640 patients are planned at $200 sites globally. Randomization is stratified by disease etiology (HBV [with or without HCV], HCV [without HBV], or other), region (Asia, other), and the presence of extrahepatic disease and/or macrovascular invasion (yes, no). OS and progression-free survival are co-primary endpoints and objective response rate is a secondary endpoint. Additional endpoints include safety, pharmacokinetics, and correlation of biomarker analyses with clinical outcomes. Enrollment in COSMIC-312 is ongoing.