OncoMatch/Clinical Trials/NCT07699939
Perioperative HLX10 (Serplulimab) With S-1+Oxaliplatin (SOX) in Locally Advanced and PD-L1-Positive Gastric or Esophagogastric Junction Adenocarcinoma
Is NCT07699939 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies serplulimab for gastric adenocarcinoma.
Treatment: serplulimab — To evaluate the clinical efficacy of perioperative treatment with S-1 + oxaliplatin (SOX)+ HLX10 compared with SOX as the control in patients with cT3-4N1-3M0 PD-L1-positive (CPS ≥ 5) locally advanced gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, in a placebo-controlled, double-blind, randomized phase II investigator-initiated clinical study.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Gastric Cancer
Esophageal Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) overexpression (CPS >= 5)
Tumor tissue determined to be PD-L1 positive (CPS >= 5) based on pre-screening evaluation by the central laboratory
Disease stage
Required: Stage CT3-4N1-3M0 (other)
Diagnosis of cT3-4N1-3M0 disease according to the AJCC/UICC-TNM 8th edition
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: immune checkpoint inhibitor
Prior treatment with other antibody or drug therapies for immune checkpoint blockade, such as PD-1, PD-L1, or CTLA-4 therapy
Lab requirements
Blood counts
Neutrophil count >= 1500/mm^3; Hemoglobin >= 9.0 g/dL; Platelet count >= 10 x 10^4/mm^3
Kidney function
Serum creatinine <= 1.5 mg/dL
Liver function
Total bilirubin <= 1.5 mg/dL; AST <= 100 U/L; ALT <= 100 U/L; Serum albumin >= 3.0 g/dL
Cardiac function
APTT <= 60 s; PT-INR <= 1.5; LVEF >= 50%
The most recent laboratory values obtained within 14 days prior to randomization meet all of the following: (1) Neutrophil count >= 1500/mm^3 (2) Hemoglobin >= 9.0 g/dL (3) Platelet count >= 10 x 10^4/mm^3 (4) Total bilirubin <= 1.5 mg/dL (5) AST <= 100 U/L (6) ALT <= 100 U/L (7) Serum albumin >= 3.0 g/dL (8) Serum creatinine <= 1.5 mg/dL (9) APTT <= 60 s (10) PT-INR <= 1.5
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07699939 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.
Does this trial require CD274?
Yes, CD274 overexpression is a required biomarker for enrollment.
What disease stage is eligible?
Stage CT3-4N1-3M0 is required.
Is there an age limit?
Yes. Patients must be 80 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.
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