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.
Age ≥ 18 years; Open to all genders;
Patients with a definitive histopathological diagnosis of gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, and an ECOG score ≤ 2;
Gastric cancer or gastroesophageal junction cancer with TNM stage IB-II;
HER-2-positive (IHC 3+ or IHC 2+ with amplification confirmed by FISH/SISH/CISH);
Other malignant tumors of the stomach;
Received, prior to screening, or is scheduled to receive during the trial any anticancer therapy other than the chemotherapy regimen specified in the protocol (e.g., radiation therapy, targeted therapy, immunotherapy);
Has or has had a malignant tumor in any other part of the body (except for adequately treated cervical carcinoma in situ, basal cell carcinoma of the skin, or other tumors that have been surgically cured and have not recurred for at least 5 years);
Unstable angina, congestive heart failure, or chronic heart failure classified as New York Heart Association (NYHA) Class ≥ 2;
Parallel
Trastuzumab
Biological/VaccineAdminister an initial loading dose of 8 mg/kg, followed by 6 mg/kg intravenously. Administer concurrently with chemotherapy, beginning on Day 1 of the first chemotherapy cycle. One cycle consists of 21 days. A total of 6 cycles are administered.
Monotherapy with tegafur for stage IB gastric cancer
DrugMonotherapy with tegafur for stage IB gastric cancer: Tegafur 40-60 mg (based on body surface area), taken orally twice daily on days 1-14. One cycle consists of 21 days, for a total of 6 cycles.
Stage II gastric cancer treated with the SOX or XELOX regimens
DrugSOX or XELOX regimens for Stage II gastric cancer: SOX regimen: Oxaliplatin 130 mg/m², administered by intravenous infusion on Day 1; tegafur 40-60 mg (based on body surface area), taken orally twice daily on Days 1-14. One cycle consists of 21 days, for a total of 6 cycles. XELOX regimen: Oxaliplatin 130 mg/m², administered by intravenous infusion on Day 1; capecitabine 1000 mg/m², administered orally twice daily on Days 1-14. One cycle consists of 21 days, for a total of 6 cycles.
5-year Disease-Free Survival (DFS).
Overall Survival (OS)
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