Statistics
ESCC
The previous CheckMate 577 study suggested that the 2-year DFS was 58% for non-pCR patients with locally advanced ESCC who received nCRT followed by radical surgery. Assuming that after perioperative immunochemotherapy and maintenance immunotherapy, the 2-year DFS increases to 75%, the trial would required 55 eligible non-pCR patients with a level of significance of 90% (α = 0.2) and a power of 90% (β = 0.05). According to the previous retrospective data analysis of our center, the pCR rate of patients with the nICT regimen followed by surgery was 26.5%, referring to the published data of the multicenter real-world study of nICT in mainland China (pCR 25.8%), and 18 additional patients would be needed further. A total of 73 patients were needed to be enrolled in this study.Two-year DFS in non-pCR patients, 2-year DFS in pCR patients and OS were calculated by the Kaplan-Meier method. The Cox proportional hazard model was used to evaluate the survival independent factors. Continuous variables are presented as the mean and standard deviation (SD). Categorical variables are presented as percentages and are compared using the chi-square test. The differences in proportions between the two groups were evaluated by Fisher’s exact test. The Wilcoxon test was used to compare the non-parametric datasets. All statistical analysis was to be calculated using SPSS (version 24.0, Chicago, IL, USA) statistical analysis software programming. 