About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- 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
- 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