Statistical Analysis
The statistical design was based on Simon's two-stage phase II optimal design (power of 80% and one-sided α of .05) to rule out an ORR of 25% and a target ORR of 43%. If there were ≥ 6 responders within the first 18 patients, the cohort would expand to 51 patients and the outcome would be positive if more than 17 patients achieved responses. Considering a 10% dropout rate, a total of 57 patients were needed.The ORR and 95% CI were calculated using the Clopper-Pearson method and compared between groups by using Fisher's exact test or chi-square test, as appropriate. The DoR, PFS, and OS were plotted using the Kaplan-Meier method. The log-rank test was used to compare Kaplan-Meier curves, and Cox proportional hazards model was adopted to determine the hazard ratio (HR) and its associated 95% CI and 