End Points
SAEs, death
SECONDARY
The primary end point was OS at 24 months, but in this first preplanned analysis, the secondary end points of ORR, hPFS, and SAEs and exploratory end points of PFS and duration of response (DOR) were reported.ORR was defined as the proportion of patients who had a partial or complete response (CR) to therapy. PFS was defined as the time from random assignment to documented progression at any site or death from any cause, and hPFS from random assignment to progression in the liver or death from any cause, both according to RECIST 1.1 criteria. ORR was defined as the percentage of patients with a best overall response (BOR) of CR or partial response (PR) according to RECIST. DOR was defined as the time from the first documented response to radiologic progression according to RECIST 1.1 criteria. Efficacy was assessed in the intention-to-treat population, with all patients included in the treatment group to which they were randomly assigned.SAEs were assessed in the per-protocol (PP) population, which was defined as all patients who underwent random assignment and were grouped according to the treatment that they received. The observation time in this analysis was defined from random assignment to the time point of starting second-line therapy or death from any cause.