OncoMatch/Clinical Trials/NCT07492615
A Clinical Study of Sintilimab Combined With Chemothrapy Versus Chemotherapy as Adjuvant Therapy for Gastric/Gastroesophageal Junction Adenocarcinoma
Is NCT07492615 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Sintilimab and S-1 & Oxaliplatin for gastric cancer or gastroesophageal junction adenocarcinoma.
Treatment: Sintilimab · S-1 & Oxaliplatin — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Esophageal Carcinoma
Biomarker criteria
Required: MMR deficiency (dMMR) by immunohistochemistry (IHC)
Diagnosed with mismatch repair deficiency (dMMR) by immunohistochemistry (IHC) of biopsy tissue
Required: MSI microsatellite instability-high (MSI-H) by genetic sequencing
microsatellite instability-high (MSI-H) by genetic sequencing
Disease stage
Required: Stage PTNM STAGE IIIC, PTNM STAGE IIIA, PTNM STAGE IIIB (pTNM)
Diagnosed with pTNM stage IIIC or pTNM stage IIIA/IIIB
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: surgery
Underwent D2 or more extensive radical resection and achieved R0 resection
Cannot have received: anti-PD-1 therapy
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.)
Cannot have received: systemic therapy with Chinese patent medicines with anti-tumor indications or immunomodulatory drugs (thymosin, interferons, interleukins)
Exception: except for local use to control pleural effusion
Received systemic therapy with Chinese patent medicines with anti-tumor indications or immunomodulatory drugs (including thymosin, interferons, interleukins, except for local use to control pleural effusion) within 2 weeks prior to first dose
Lab requirements
Blood counts
ANC ≥1.5×10^9/L without G-CSF within past 14 days; platelets ≥100×10^9/L without transfusion within past 14 days; hemoglobin >9 g/dL without transfusion or erythropoietin within past 14 days.
Kidney function
Serum creatinine ≤1.5×ULN and creatinine clearance (Cockcroft-Gault) ≥60 ml/min.
Liver function
Total bilirubin ≤1.5×ULN; if total bilirubin >1.5×ULN but direct bilirubin ≤ULN, enrollment is also permitted. AST and ALT ≤2.5×ULN.
Cardiac function
Cardiac enzyme panel within normal range (isolated laboratory abnormalities deemed clinically insignificant by the investigator are also permitted for enrollment).
Adequate organ function, subjects must meet the following laboratory criteria: ... (see full criteria above)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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