Statistical analysis
TTP
TTP
An ORR ≥ 40% was considered clinically acceptable and the expected ORR was 55%. One hundred and twenty-two patients were required to achieve a lower limit of the two-sided 95% CI of 40%, with a one-sided α of 0.025 and a power of 80%. Considering a dropout rate of 15%, a total sample size of 144 patients was required.95% CIs for ORR and DCR were calculated using the Clopper-Pearson method. The median DoR, median PFS, median TTP, median OS, and corresponding 95% CIs were calculated using the Kaplan-Meier method. C