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

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.

NCT Number	NCT04483076
Lead Sponsor	Chinese PLA General Hospital
Conditions	Gastric Cancer, Chemotherapy Effect
Enrollment	524 participants
Start Date	2021-01-13
Primary Completion	2022-12 (estimated)
Study Completion	2028-12 (estimated)
Updated on ClinicalTrials.gov	2021-01-20