Statistical analysis
This was a single-arm study, and no randomization was used. To determine the sample size for this clinical trial, overall survival (OS) with standard of care chemotherapy (Gem/Cis) as the historical control was assumed to be 9.5 months based on previously reported data of Asian populationStatistical analyses and graph illustration were performed using SAS 9.4 (SAS Institute, Cary, NC, USA) and R 4.1.3. Survival was analyzed using Kaplan–Meier curves and log-rank test, and values of 