To evaluate efficacy and safety of peri-operative sintilimab in combination with SOX in resectable locally advanced gastric or gastroesophageal junction adenocarcinoma
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
210
Sintilimab, 200mg IV d1 Q3W
S-1, 40-60mg BID d1-14 Q3W
Oxaliplatin,130mg/m2 d1 Q3W
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGPathological complete response (pCR) rate
Pathological complete response (pCR) rate is defined as the proportion of participants whose tumor in the stomach and lymph node completely disappeared, as determined by a pathologist.
Time frame: up to 8 weeks after surgery
Tumor down-staging rate
Tumor down-staging is defined as any stage reduction between clinical and pathologic stage
Time frame: up to 8 weeks after surgery
Major pathological response (MPR) rate
Major pathological response (MPR) rate is defined as the proportion of participants whose percentage of residual tumor in the stomach and lymph node decreased to \< 10%, as determined by a pathologist.
Time frame: up to 8 weeks after surgery
3 years disease-free survival (DFS) rate
3 years disease-free survival (DFS) rate is defined as proportion of participants who have no recurrence or metastasis after 3 years of radical treatment
Time frame: up to 4 years
5 years overall survival (OS) rate
5 years overall survival (OS) rate is defined as proportion of participants who survived 5 years after radical treatment
Time frame: up to 6 years
Adverse event
All grades of adverse events, all grades of treatment related adverse events, serious of adverse events
Time frame: up to 30 days after last treatment administration
Overall response rate ( ORR)
Overall response rate ( ORR) is defined as proportion of participants who have a best response of CR or PR
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Time frame: up to 30 days after last preoperative treatment administration
Disease Control Rate (DCR)
Disease Control Rate (DCR) is defined as proportion of participants who have a best response of CR、PR or SD
Time frame: up to 30 days after last preoperative treatment administration