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 (Jun 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
Treatments studied
Chemotherapy
Other
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)
Demographics
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.
Frequently asked questions
Is NCT06461910 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 ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
What disease stage is eligible?
Stage CSTAGE III (CT3-4AN1-3M0) is required.
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