To evaluate the clinical efficacy and safety of Tislelizumab combined with apatinib mesylate, oxaliplatin plus S1 Vs oxaliplatin plus S1.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
130
Participants will receive Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks for 4 cycles. Discontinuation will be considered due to toxicity, withdrawal of consent, or end of study. Every 3-week treatment period was considered to be a cycle.
Participants will receive apatinib, 250mg, qd,every 3 weeks for 3 weeks
Participants will receive oxaliplatin, 130mg/m2, day 1 of every 3 weeks for 4 weeks.
Fujian cancer hospital
Fuzhou, Fujian, China
RECRUITINGPathological complete response
Total tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell
Time frame: 4 weeks after surgery
Major pathological response
Total/moderate tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell
Time frame: 4 weeks after surgery
Objective Response Rate (ORR)
Objective Response Rate Determine the tumor shrinkage rate, tumor boundary and the adhesion of tumor
Time frame: At the end of Cycle 3 (each cycle is 21 days)]
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Participants will receive S-1, day 1-14 of every 3 weeks for 4 weeks.