A Clinical Study Comparing Anti-HER2 Therapy Combined With Chemotherapy to Chemotherapy Alone as Adjuvant Therapy Following Surgery for Stage IB-II Gastric Cancer With High HER2 Expression.

This study employs a multicenter randomized controlled trial design, led by the First Affiliated Hospital of Air Force Medical University (Xijing Hospital) in collaboration with 10 other domestic medical institutions, for a total of 11 research centers. The study plans to enroll a total of 120 HER-2-positive gastric cancer patients, including those who drop out, and randomize them into two groups in a 1:1 ratio; The control group received treatment based on gastric cancer stage: Stage IB patients were treated with tegafur monotherapy (40-60 mg orally twice daily based on body surface area, on days 1-14, with a 21-day cycle, for a total of 6 cycles); Stage II patients will receive chemotherapy using either the SOX or XELOX regimen, both of which involve an intravenous infusion of oxaliplatin 130 mg/m² on Day 1, combined with the corresponding oral medications for 14 consecutive days, with a 21-day cycle, for a total of 6 treatment cycles; In addition to the control group's original chemotherapy regimen, the experimental group concurrently received Fuhong Hanlin trastuzumab (National Drug Approval No. S20200019, 150 mg/vial) in addition to the control group's original chemotherapy regimen. The first dose was an 8 mg/kg intravenous loading dose, followed by a maintenance dose of 6 mg/kg, administered concurrently starting on the first day of the first chemotherapy cycle, with each cycle lasting 21 days, and the treatment course consisting of 6 cycles.