The trial is a prospective, randomized, controlled phase Ⅱ study which will be conducted in Chinese PLA General Hospital, Beijing, China. Patients with eligibility will enrolled and assigned into either group A for 9 weeks of nivolumab, S-1 combined with oxaliplatin (Nivo+SOX) followed by D2 surgery and group B for 9 weeks of nivolumab followed by D2 surgery. The primary endpoint is the safety assessed by recording adverse events and the secondary endpoints are response rate, disease control rate, pathological complete response rate, D2 rate and R0 rate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
The preoperative therapy consists of three-week cycles of intravenously administered nivolumab 360mg and oxaliplatin 130mg/m2 on day 1, and orally administered S-1 40-60 mg twice a day (BID) on day 1 to 14. The dose of S-1 depends on body surface area (BSA): BSA\<1.25 m2, 40mg; 1.25\<BSA\<1.50 m2, 50mg; BSA\>1.50 m2, 60mg. Day 15 to day 21 is the rest period.
The preoperative therapy consists of three-week cycles of intravenously administered nivolumab 360mg on day 1.
A standard D2 radical laparoscopic gastrectomy according to the CSCO clinical guidelines for the diagnosis and treatment of gastric cancer is planned 3-4 weeks after the last cycle of preoperative therapy.
Adverse events
The safety is assessed by recording adverse events.
Time frame: 2 years
RR
Response rate, defined as the rate of patients who achieve CR or PR according to the RESIST 1.1.
Time frame: 2 years
DCR
Disease control rate, defined as the rate of patients who achieve CR, PR or PD according to the RESIST 1.1.
Time frame: 2 years
pCR rate
Pathological complete response rate, defined as the rate of patients achieving pathological complete response.
Time frame: 2 years
D2 rate
The rate of patients who received D2 radical gastrectomy.
Time frame: 2 years
R0 rate
The rate of patients who received R0 resection.
Time frame: 2 years
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