OncoMatch/Clinical Trials/NCT05593458
Transarterial Neoadjuvant Chemotherapy vs.Traditional Intravenous Chemotherapy For Locally Advanced Gastric Cancer With SOX+PD-1
Is NCT05593458 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for locally advanced gastric carcinoma.
Treatment: Oxaliplatin by arterial infusion plus S-1 · SOX neoadjuvant · Sintilimab neoadjuvant · SOX adjuvant, Sequential S-1 · Sintilimab adjuvant — SOX regimen, consisting of oral S-1 and intravenous oxaliplatin, is the preferred regimen for perioperative chemotherapy for gastric cancer. The goal of this clinical trial is to compare the efficacy and safety between S-1 combined with oxaliplatin by arterial infusion, as neoadjuvant chemotherapy, and conventional SOX regimen, in locally advanced gastric cancer. The main question it aims to answer is: whether arterially infused oxaliplatin plus S-1 has the potential to be a better neoadjuvant option for patients with locally advanced gastric cancer. Participants will be randomised, and receive: * 3 cycles of conventional SOX chemotherapy plus PD-1 antibody or arterial infused oxaliplatin plus S-1 and PD-1 antibody, as neoadjuvant chemotherapy; * Adequate gastric resection along with D2 lymph node dissection; * 3 cycles adjuvant chemotherapy using SOX regimen plus PD-1 antibody. * Administration of S-1 regularly till 1 year after surgery. Researchers will compare Major pathological response rate (MPR) ，pathologic complete response rate（pCR）,the 2-year overall survival (OS) rates, 2-year disease free survival (DFS), R0 resection rates, and adverse events, to see if the modified perioperative chemotherapy improve the prognosis of patients with locally advanced gastric cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Biomarker criteria
Excluded: HER2 (ERBB2) overexpression (+++) confirmed by immunohistochemistry
HER2 overexpression(+++) confirmed by immunohistochemistry [excluded].
Disease stage
Required: Stage CT3N2-3M0, CT4AN1-3M0, CT4BNANYM0
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: cytotoxic chemotherapy
Cannot have received: radiotherapy
Cannot have received: immunotherapy
Lab requirements
Blood counts
White Blood Cell count ≥3 × 10^9/L, ANC ≥ 1.5 × 10^9/L, PLT ≥ 80 × 10^9/L, Hb ≥ 90 g/L
Kidney function
Cr <1.5 fold of upper limit value; Moderate or severe renal impairment: serum creatinine > 1.5 x upper limit of normal (ULN) [excluded]
Liver function
ALT/AST <2.5 fold of upper limit value; Tbil <1.5mg/dl
Cardiac function
Clinically significant (i.e. active) cardiac disease e.g. symptomatic coronary artery disease, NYHA grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication or myocardial infarction within the last 12 months [excluded]
Normal hepatic, renal, and bone marrow function (ALT/AST<2.5 fold of upper limit value;Tbil<1.5mg/dl, Cr<1.5 fold of upper limit value; White Blood Cell count≥3 × 10^9/L, ANC ≥ 1.5 × 10^9/L,PLT≥ 80 × 10^9/L,Hb ≥ 90 g/L).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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