Study design
toxicity, PD, Cancer
DISEASE, METASTASIS, CANCER
This randomized, open-label, exploratory study was conducted at a single center. Since the main purpose of the study was exploratory, no statistical assumptions were made about the sample size. Patients were randomly assigned (1:1) to receive CIK-SOX or SOX alone using the central randomization system. Randomized grouping was stratified according to the Eastern Cancer Cooperation Group (ECOG) performance status (PS) score of 0 or 1 and the current disease stage (locally advanced or metastasis). Six cycles of the SOX treatment were administered. Patients without progressive disease (PD) received autologous CIK cells combined with S-1 or S-1 as the maintenance treatment until PD or unacceptable toxicity level was achieved, or out of the group. No crossing between the two groups is allowed.The present study (ChiCTR-IPR-15005923; NCT02504229, 