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 (Jun 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
Treatments studied
Other
Cancer type
Gastric Cancer
Biomarker criteria
Excluded: HER2 (ERBB2) overexpression
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
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.
Frequently asked questions
Is NCT05918094 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Are patients with ERBB2 alterations eligible?
No. ERBB2 overexpression is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages