OncoMatch/Clinical Trials/NCT05918094
Comparing Modified XELOX Plus Sintilimab With Standard XELOX Plus Sintilimab in First-line Treatment for HER2-negative Gastric/Gastroesophageal Junction Adenocarcinoma
Is NCT05918094 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Experimental dose: modified XELOX + sintilimab and Standard dose: standard XELOX + sintilimab for gastric cancer.
Treatment: Experimental dose: modified XELOX + sintilimab · Standard dose: standard XELOX + sintilimab — This is a randomized, controlled, multicenter phase Ⅲ study to evaluate the therapeutic efficacy of modified XELOX plus sintilimab versus standard XELOX plus sintilimab in subjects with advanced HER2-negative gastric or gastroesophageal adenocarcinoma in the first-line treatment. The primary outcome is the progression-free survival (PFS), with a planned enrollment of 540 subjects.
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Biomarker criteria
Excluded: HER2 (ERBB2) overexpression
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: immune checkpoint inhibitor (anti-PD-1 antibody, anti-PD-L1 antibody, CTLA-4 antibody)
Prior exposure to any immune checkpoint inhibitors (anti-PD-1 antibody, anti-PD-L1 antibody, CTLA-4 antibody)
Cannot have received: cytotoxic chemotherapy
Receiving antitumor cytotoxic drugs, biological drugs (such as monoclonal antibodies), immunotherapy (such as interleukin 2 or interferon), or other investigational treatments within 4 weeks prior to enrollment
Cannot have received: biological therapy (monoclonal antibodies)
Receiving antitumor cytotoxic drugs, biological drugs (such as monoclonal antibodies), immunotherapy (such as interleukin 2 or interferon), or other investigational treatments within 4 weeks prior to enrollment
Cannot have received: immunotherapy (interleukin 2, interferon)
Receiving antitumor cytotoxic drugs, biological drugs (such as monoclonal antibodies), immunotherapy (such as interleukin 2 or interferon), or other investigational treatments within 4 weeks prior to enrollment
Cannot have received: radiation therapy
Receiving radiotherapy within 4 weeks prior to the first dose
Lab requirements
Blood counts
ANC ≥ 1.5×10^9/L; platelet count ≥ 75×10^9/L; hemoglobin ≥ 7.5 g/dL
Kidney function
serum creatinine (Cr) ≤ 1.5 x ULN, or creatinine clearance >50 mL/min
Liver function
serum total bilirubin (TBIL) ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN in subjects without liver metastases, and ALT and AST ≤ 5.0 × ULN in subjects with liver metastases; serum albumin ≥ 25 g/L
Subjects having adequate organ and bone marrow functions with laboratory test values within 7 days prior to enrollment meeting the following requirements...
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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