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OncoMatch/Clinical Trials/NCT04483076

Oxaliplatin Combined With S-1(SOX) Neoadjuvant Chemotherapy for Different Cycles in Patients With Gastric Cancer

Is NCT04483076 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Chemotherapy drug for gastric cancer.

Phase 3RecruitingChinese PLA General HospitalNCT04483076Data as of May 2026

Treatment: Chemotherapy drugRESONANCE-II trial is a prospective, multicenter, randomized, controlled phase III study which will enroll 524 patients in total. Patients with eligibility will be registered, pre-enrolled and receive three cycles of SOX. Then, tumor response evaluation will be carried out. Those who achieve stable disease or progressive disease will be excluded. Patients achieving complete response or partial response will be enrolled and assigned into either group A for another three cycles of SOX (six cycles in total) followed by D2 surgery and group B for D2 surgery (three cycles in total). The primary endpoint is the rate of pathological complete response and the secondary endpoints are R0 resection rate, three-year disease-free survival, five-year overall survival and safety.

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Extracted eligibility criteria

Cancer type

Gastric Cancer

Disease stage

Required: Stage III

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: chemotherapy

Received any chemotherapy, radiotherapy or immunotherapy before

Cannot have received: radiotherapy

Received any chemotherapy, radiotherapy or immunotherapy before

Cannot have received: immunotherapy

Received any chemotherapy, radiotherapy or immunotherapy before

Lab requirements

Blood counts

hemoglobin (Hb) ≥ 90 g/L, neutrophil absolute count ≥ 3×10^9 /L, platelet count (PLT) ≥ 100×10^9 /L, serum albumin (ALB) ≥ 30 g/L

Kidney function

serum creatinine (SCr) ≤ 1.5×ULN

Liver function

ALT and AST ≤ 2.5 times the upper limit of normal (ULN), total bilirubin ≤ 1.5×ULN

Cardiac function

left ventricular ejection fraction ≥ 50%, ECG basically normal within 4 weeks before operation and without obvious symptoms

Laboratory test criteria: peripheral blood hemoglobin (Hb) ≥ 90 g/L, neutrophil absolute count ≥ 3×10^9 /L, platelet count (PLT) ≥ 100×10^9 /L, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal (ULN), total bilirubin ≤ 1.5×ULN, serum creatinine (SCr) ≤ 1.5×ULN, and serum albumin (ALB) ≥ 30 g/L; Patients with heart disease, the echocardiogram showed that the left ventricular ejection fraction ≥ 50%, the electrocardiogram (ECG) is basically normal within 4 weeks before operation and without no obvious symptoms are acceptable

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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