OncoMatch/Clinical Trials/NCT06461910
Efficacy and Safety of Anti-PD-1, Thymalfasin, and SOX in Neoadjuvant Treatment of cStage III Gastric/Gastroesophageal Junction Adenocarcinoma
Is NCT06461910 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Serplulimab and thymalfasin for gastric cancer.
Treatment: Serplulimab · thymalfasin · Oxaliplatin · Tegafur — This Phase II clinical study is a prospective, open-label, single-arm trial designed to evaluate the efficacy and safety of combining anti-PD-1 therapy (Serplulimab) with thymalfasin and the SOX chemotherapy regimen as a neoadjuvant treatment for patients with clinical stage III gastric or gastroesophageal junction(GEJ) adenocarcinoma.
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Biomarker criteria
Required: HER2 (ERBB2) wild-type
Disease stage
Required: Stage CSTAGE III (CT3-4AN1-3M0) (AJCC 8th edition)
According to the 8th edition of AJCC staging for gastric cancer, patients must be assessed via abdominal CT as cStage III (cT3-4aN1-3M0).
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: surgery
Patients must not have received prior systemic treatment for the current disease, including surgery, anti-tumor chemotherapy, radiotherapy, or immunotherapy.
Cannot have received: chemotherapy
Patients must not have received prior systemic treatment for the current disease, including surgery, anti-tumor chemotherapy, radiotherapy, or immunotherapy.
Cannot have received: radiation therapy
Patients must not have received prior systemic treatment for the current disease, including surgery, anti-tumor chemotherapy, radiotherapy, or immunotherapy.
Cannot have received: immunotherapy
Patients must not have received prior systemic treatment for the current disease, including surgery, anti-tumor chemotherapy, radiotherapy, or immunotherapy.
Lab requirements
Blood counts
ANC ≥ 1.5 x 10^9/L without G-CSF for past 14 days; Platelet count ≥ 100 x 10^9/L without transfusion for past 14 days; Hemoglobin > 9 g/dL without transfusion or erythropoietin for past 14 days.
Kidney function
Serum creatinine ≤ 1.5 x ULN and creatinine clearance (using Cockcroft-Gault formula) ≥ 60 ml/min.
Liver function
Total bilirubin ≤ 1.5 x ULN; if > 1.5 x ULN, direct bilirubin must be ≤ ULN. AST and ALT ≤ 2.5 x ULN.
Cardiac function
Good cardiac function, suitable for curative surgery. Preoperative evaluation by a cardiologist is required if there are clinical indications of underlying ischemic, valvular, or other severe heart diseases. Normal myocardial enzyme spectrum (clinical judgment for non-significant lab abnormalities is acceptable).
Normal function of major organs, meeting the following laboratory criteria: Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L without granulocyte colony-stimulating factor for the past 14 days. Platelet count ≥ 100 x 10^9/L without transfusion for the past 14 days. Hemoglobin > 9 g/dL without transfusion or erythropoietin use for the past 14 days. Total bilirubin ≤ 1.5 x upper limit of normal (ULN); if > 1.5 x ULN, direct bilirubin must be ≤ ULN. AST and ALT ≤ 2.5 x ULN. Serum creatinine ≤ 1.5 x ULN and creatinine clearance (using Cockcroft-Gault formula) ≥ 60 ml/min. Normal coagulation function (INR or PT ≤ 1.5 x ULN). Normal thyroid function (TSH within normal range, or normal T3/FT3 and FT4 if baseline TSH is out of range). Normal myocardial enzyme spectrum (clinical judgment for non-significant lab abnormalities is acceptable).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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