Statistical analysis
A Simon’s 2-stage design was adopted in this study, with a one-sided All participants who underwent at least one study treatment were considered for both efficacy and safety analyses. Both ORR and DCR were presented with their two-sided 95% CI: calculated using the Clopper-Pearson approach. The median values for time-to-event variables were determined through the Kaplan–Meier technique, and their respective 95% CI were derived using the Brookmeyer and Crowley method. All statistical evaluations were carried out using SAS® software (version 9.4, SAS Institute Inc, Cary, USA).