Patients will be randomly assigned in a 2:1 allocation ratio to receive nivolumab combined with chemotherapy followed by MIE (arm A, nIT + nCT group) or placebo + nCT followed by MIE (arm B, nCT group) and were stratified according to coordinating centers. Randomization will be assigned by the central dynamic, computer-generated random system. The stratification factors include age, tumor location and clinical staging. The research center will generate assignments in the random system online after enrollment.
The study will use an internally blinded double-blind approach. Nivolumab and normal saline were in the same package, and the corresponding labels were prepared and affixed on site to maintain blindness. Subjects, investigators and sponsor staff who participated in subject treatment or clinical evaluation were unaware of the assignments. Only the open-label pharmacist/nurse will obtain each subject’s study identification number and study drug assignment from the central randomization system and prepare the drugs.
The study will use an internally blinded double-blind approach. Nivolumab and normal saline were in the same package, and the corresponding labels were prepared and affixed on site to maintain blindness. Subjects, investigators and sponsor staff who participated in subject treatment or clinical evaluation were unaware of the assignments. Only the open-label pharmacist/nurse will obtain each subject’s study identification number and study drug assignment from the central randomization system and prepare the drugs.
