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 FirstAffiliated Hospital of Air Force Medical University (Xijing Hospital) in collaborationwith 10 other domestic medical institutions, for a total of 11 research centers. Thestudy plans to enroll a total of 120 HER‐2‐positive gastric cancer patients, includingthose who drop out, and randomize them into two groups in a 1:1 ratio; The control groupreceived treatment based on gastric cancer stage: Stage IB patients were treated withtegafur monotherapy (40‐60 mg orally twice daily based on body surface area, on days1‐14, with a 21‐day cycle, for a total of 6 cycles); Stage II patients will receivechemotherapy using either the SOX or XELOX regimen, both of which involve an intravenousinfusion of oxaliplatin 130 mg/m² on Day 1, combined with the corresponding oralmedications for 14 consecutive days, with a 21‐day cycle, for a total of 6 treatmentcycles; In addition to the control group's original chemotherapy regimen, theexperimental group concurrently received Fuhong Hanlin trastuzumab (National DrugApproval No. S20200019, 150 mg/vial) in addition to the control group's originalchemotherapy regimen. The first dose was an 8 mg/kg intravenous loading dose, followed bya maintenance dose of 6 mg/kg, administered concurrently starting on the first day of thefirst chemotherapy cycle, with each cycle lasting 21 days, and the treatment courseconsisting of 6 cycles.