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 is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek co najmniej 18 lat, wszystkie płci
- •Potwierdzony rak żołądka lub połączenia przełyku ze żołądkiem na stadium IB-II
- •Białko HER2-dodatnie w badaniu patologicznym
- •Guz całkowicie usunięty chirurgicznie
- •Prawidłowa funkcja wątroby, nerek i serca
- •Wystarczająca liczba komórek krwi (neutrofile, płytki, hemoglobina)
- •Normalne funkcje tarczycy
- •Świadoma zgoda na udział w badaniu
✗ Disqualifies
- •Inne złośliwe nowotwory żołądka
- •Poprzednia chemioterapia lub zaplanowana inna terapia przeciwnowotworowa podczas badania
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- August 26, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
The First Affiliated Hospital of Air Force Military Medical University
Xi'an, China
Trial contact
Yongzhan Nie
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/27/2026.
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