Endpoints
death, SD, Cancer
DISEASE PROGRESSION, ADVERSE EVENT, ADVERSE EVENT, DISEASE, CANCER
The primary endpoint was PFS evaluated by investigators, defined as the time elapsed from patient enrollment to the first disease progression or death from any cause, whichever occurred first. Secondary endpoints included the objective response rate (ORR), disease control rate (DCR), and OS. ORR was defined as the proportion of patients achieving a complete (CR) or partial response (PR). DCR was defined as the proportion of participants who achieved CR, PR, and stable disease (SD). OS was defined as the time elapsed from patient enrollment to death from any cause or censored at the data cutoff date. Adverse events (AEs) were recorded and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.