Statistical analysis
PD, death, SD, tumor
DISEASE, SECONDARY, REMISSION, TUMOR
The purpose of the present study was to explore the safety and effectiveness of the CIK-SOX regimen. The primary end point was the incidence of AEs. The AE evaluation was calculated and classified according to CTCAE v4.0. The secondary end points were progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and disease control rate (DCR). PFS was defined as the earliest evidence from randomization to PD (according to RECIST v1.1) or the time of death from any cause, whichever occurred first. OS was defined as the time from randomization to death for any reason. Patients who survived and did not progress at the last disease assessment were reviewed. ORR was defined as the proportion of patients with complete remission (CR) or partial remission (PR). DCR was defined as the proportion of patients with CR, PR, or stable disease (SD). The safety endpoint was based on the safety set (SS), in which the patient received at least one protocol treatment and one safety evaluation. The efficacy end point was based on the full analysis set (FAS), in which the population received at least one protocol treatment and had one tumor evaluation. The median follow-up period of the entire study cohort was calculated according to the reverse Kaplan-Meier method. Kaplan-Meier survival curve was used to estimate OS and PFS and log-rank test was used to evaluate the differences between treatment groups. The Cox proportional hazards model was used to estimate the risk ratio. All statistical tests were bidirectional, and 