Endpoints
death, SD, Toxicity
DISEASE PROGRESSION, ADVERSE EVENTS, DISEASE, EVENTS, PATHOLOGY
The primary endpoint was OS, which indicates the day from the first dose of GemCis or sintilimab to death from any cause. Secondary endpoints included progression-free survival (PFS; the day from the first dose to disease progression or death), ORR, the proportion of complete response rate plus partial response (PR) rate under computerized tomography, and disease control rate [DCR; the proportion of patients who achieved CR plus PR and Supplementary Table disease (SD)]. As to render safety, adverse events (AEs) in the entire study process were reported as per CTCAE V.5.0. Imaging and pathology were confirmed by two clinical specialists. Investigators evaluated the responses based on RECIST V.1.1. Toxicity profile included the events occurring 30 days after the end of therapy in all patients. Multiomics biomarkers associated with clinical response were assessed as an exploratory objective.