This study aims to explore the efficacy and safety of sintilimab combined with SOX versus SOX alone as adjuvant therapy for patients with pIIIC stage or dMMR/MSI-H pIIIA/IIIB stage gastric/gastroesophageal junction adenocarcinoma. A total of 276 subjects are planned to be enrolled in this study. Patients will be randomly assigned in a 1:1 ratio to receive up to 8 cycles of sintilimab combined with SOX or SOX alone as adjuvant therapy.
Signed written informed consent.
Male or female, age ≥18 years.
Histopathologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (GEJ).
Diagnosed with pTNM stage IIIC or pTNM stage IIIA/IIIB.
Cancers involving the EGJ with the tumor center located in the proximal stomach ≤2 cm from the EGJ.
Diagnosis of any other malignant disease other than gastric cancer within 5 years prior to first dose (excluding curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or curatively resected carcinoma in situ).
Currently participating in interventional clinical study treatment, or has received other investigational drugs or used investigational devices within 4 weeks prior to first dose.
Prior receipt of the following therapies: anti-PD-1, anti-PD-L1, or drugs targeting another stimulatory or co-inhibitory T-cell receptor (including but not limited to CTLA-4, OX-40, CD137, etc.).
Parallel
Sintilimab
Drug200 mg, administered intravenously, d1, every 3 weeks
S-1 & Oxaliplatin
DrugS-1:Oral, 40-60 mg, twice daily (bid), d1-14, every 3 weeks. Oxaliplatin: 130 mg/m², administered intravenously on Day 1 (d1), every 3 weeks.
3-year disease-free survival (3yr-DFS)
DFS is defined as time from randomization to disease recurrence (determined by CT or MRI scan and/or pathologic disease on biopsy) or death (from any cause) by investigator assessment. 3-year DFS rate is Disease-Free Survival at 3 Years.
disease-free survival (DFS)
DFS is defined as time from randomization to disease recurrence (determined by CT or MRI scan and/or pathologic disease on biopsy) or death (from any cause) by investigator assessment.
Overall Survival(OS)
OS is defined as the time from the date of randomisation until death due to any cause.
Adverse events(all grades）
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