A Prospective, Multicenter, Randomized, Controlled Phase III Study Evaluating Different Cycles of Oxaliplatin Combined With S-1 (SOX) as Neoadjuvant Chemotherapy for Patients With Locally Advanced Gastric Cancer: RESONANCE-II Trial
RESONANCE-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.
• Non-bedridden, aged 18 to 70 years old;
• Eastern Cooperative Oncology Group (ECOG) score is 0 to 1;
• Histologically confirmed gastric adenocarcinoma;
• Stage III (American Joint Committee on Cancer (AJCC) TNM staging system 8th edition) gastric cancer confirmed by enhanced computer tomography (enhanced CT) and laparoscopic exploration (endoscopic ultrasonography (EUS) and magnetic resonance imaging (MRI) if necessary);
• The research center and the surgeon have the ability to complete standard D2 radical gastrectomy, and the gastrectomy can be tolerated by the patient;
• Laboratory test criteria: peripheral blood hemoglobin (Hb) ≥ 90 g/L, neutrophil absolute count ≥ 3×109 /L, platelet count (PLT) ≥ 100×109 /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;
• There is no serious underlying disease that could lead to an expected life expectancy \< 5 years;
• Willing to sign the inform consent for participation and publication of results.