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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Administer 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: 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.
SOX 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.
The First Affiliated Hospital of Air Force Military Medical University
Xi'an, Shaanxi, China
RECRUITING5-year Disease-Free Survival (DFS).
Time frame: 5 years after study randomization
Overall Survival (OS)
Time frame: Up to 5 years after patient randomization
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