This study evaluates the clinical efficacy and safety benefits of immunotherapy in a selected patient population by comparing serplulimab combined with short-course SOX regimen versus SOX regimen alone as adjuvant therapy for patients with stage pII-III gastric or gastroesophageal junction (G/EGJ) adenocarcinoma who are PD-L1 CPS ≥5, EBV-positive, or dMMR/MSI-H.
The patient voluntarily joins this study and signs the informed consent form.
Age ≥18 years and ≤75 years, male or female.
Histologically confirmed gastric or gastroesophageal junction (GEJ) adenocarcinoma (predominantly adenocarcinoma) with stage II-III disease (TNM staging, 8th UICC/AJCC) who have not received preoperative neoadjuvant therapy.
ECOG performance status: 0-1.
The patient voluntarily joins this study and signs the informed consent form. (Note: This item appears to be an inclusion criterion and is likely misplaced. Please verify.)
Pregnant or breastfeeding women.
Women of childbearing potential with a positive baseline pregnancy test.
Distant metastasis diagnosed by CT/MRI/EUS.
Parallel
Standard Treatment Group: SOX regimen for up to 6 cycles Oxaliplatin: 130 mg/m², i.v., D1, Q3W; S-1 (Tegafur-Gimeracil-Oteracil Potassium): Oral administration: 40 mg per dose for BSA < 1.25, 50 mg pe
DrugSOX
Experimental Immunotherapy Group: Phase I: Combination Therapy Period (First 3 Cycles) Oxaliplatin: 130 mg/m², intravenous infusion, Day 1, every 3 weeks (Q3W), for 3 cycles. Serplulimab: 300 mg, i
DrugSerplulimab+SOX
3yr-RFS rate
Defined as the proportion of patients who have not developed local or regional recurrence or distant metastasis from randomization to the 3-year follow-up, excluding second primary malignancies and non-tumor-related deaths.
Recurrence-Free Survival (RFS)
Defined as the time from randomization to the occurrence of local or regional recurrence or distant metastasis, excluding second primary malignancies and non-tumor-related deaths. If a patient does not experience disease progression during the study period, RFS is defined as the time to the last date on which the patient was confirmed to be progression-free.
Overall Survival (OS)
Overall survival is defined as the time from patient enrollment to death from any cause. For patients who are still alive at the last follow-up, OS is censored at the date of last follow-up. For patients lost to follow-up, OS is censored at the last date on which the patient was confirmed to be alive prior to loss to follow-up. Censored OS is defined as the time from enrollment to censoring.
Safety
All adverse events occurring in patients during the clinical study period will be monitored, including clinical symptoms, abnormal vital signs, and laboratory test abnormalities. The clinical characteristics, severity, time of onset, duration, management, and outcome of each adverse event will be recorded, and the causal relationship with the investigational drug will be assessed. Drug safety will be evaluated using the NCI-CTCAE Version 5.0 criteria.
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