Statistical analyses
We estimated that a sample size of 30 patients would ensure at least 80% power to detect the ORR increase from 15% of anti-PD-1 monotherapy to 35% of cadonilimab combined with lenvatinib when the one-side type I error was 0.025.The full-analysis set (FAS) was defined as enrolled patients who received at least one dose of study drug and has measurable target lesion (per RECIST v1.1) at baseline. The safety set (SS) was defined as enrolled patients who received at least one dose of study drug and has data recorded after treatment.ORR and DCR with corresponding two-sided 95% CIs were estimated using the Clopper-Pearson method. Kaplan–Meier methods were applied to estimate DoR, PFS, and OS. Statistical analyses were performed using SAS software, version 9.4.