Statistical analysis
This study was a superiority trial using Simon’s two-stage design to estimate the sample size. The one-sided Efficacy and survival were analyzed in the intention-to-treat (ITT) cohort, which included patients who received at least one cycle of test drugs, and the per-protocol cohort (PP), which excluded those who accepted other anti-tumor treatment during the study period on the basis of the ITT cohort. The safety cohort covered all patients who received at least one cycle of test drugs and had safety records available after medication. The Kaplan–Meier method was used to calculate the DoR, PFS, and OS. The corresponding 95% CIs of ORR and DCR were calculated based on the Clopper-Pearson exact method. In post hoc subgroup analyses, the chi-square test was used to compare ORR in different subgroups. All statistical tests were two-sided, and a 