Statistical analysis
death
DISEASE
All 19 participants received at least two cycles neoadjuvant therapy and one efficacy assessment and were eligible for the efficacy analyses. We had hypothesized that, with our proposed neoadjuvant treatment, the R0 resection would increase to 56% from a prior historical proportion of 37%. Forty‐four evaluable patients were required to achieve 83% power using a 2‐sided binomial test at 10% significance level. The Simon's two‐stage minimax design was used based on the null and alternative hypothesis (37% vs. 56%). For the first‐stage, 19 subjects were required for interim analysis, and the trial would be stopped if 7 or fewer subjects underwent R0 resection. If 8 or more R0 resections were achieved, then the study would proceed until the intended sample size of 44. Time‐to‐event endpoints were estimated using the Kaplan–Meier method and report an associated 95% confidence interval (CI). Progression‐free survival (PFS) was measured from the first dose of study drug until progression or death, censoring at the time of last disease assessment. Among the resected, relapse‐free survival was estimated from the date of resection until progression or death, censoring at the time of last disease assessment. Survival was measured from the first dose of study drug until death, censoring at the date of last contact. Response evaluations were reported as proportions with 95% CIs calculated using the binomial exact method. Baseline characteristics were reported as frequency and percent (categorical variables) or median and range (minimum and maximum, continuous variables). All data were analyzed using SAS version 9.4 (SAS Institute Inc.).