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A Randomized, Controlled, Open-Label, Multi-center Clinical Study Comparing the Efficacy of Close Follow-Up Versus Adjuvant Chemotherapy in Patients With Stage IB-IIA Gastric or Gastroesophageal Junction Adenocarcinoma Following Radical Surgery
Sponsor: Xijing Hospital
Summary
This study is a randomized, controlled, open-label, multicenter trial. Patients who underwent radical resection for stage IB-IIA gastric or gastroesophageal junction adenocarcinoma were enrolled and stratified into low-risk and high-risk groups based on the presence of lymph node metastasis, vascular invasion, or elevated preoperative tumor markers (CEA or CA19-9). Patients in the low-risk group were directly enrolled in follow-up observation, while those in the high-risk group were randomized 1:1 to either close follow-up or adjuvant chemotherapy. The primary endpoint of the study is the efficacy and safety of adjuvant chemotherapy following radical resection in patients with stage IB-IIA gastric or gastroesophageal junction adenocarcinoma.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
500
Start Date
2026-08-10
Completion Date
2036-01-31
Last Updated
2026-08-07
Healthy Volunteers
No
Interventions
Tegafur Gimeracil Oteracil Potassium Capsules for oral administration
Tegafur Gimeracil Oteracil Potassium Capsules for oral administration, dosage regimen:Body surface area (BSA) \<1.25 m²: 40 mg per dose, twice daily; 1.25 m² ≤ BSA \<1.5 m²: 50 mg per dose, twice daily; BSA ≥1.5 m²: 60 mg per dose, twice daily. Medication is administered consecutively for 14 days followed by a 7-day drug-free interval to complete one treatment cycle, with a total of 8 cycles planned.
Locations (1)
The First Affiliated Hospital of Air Force Military Medical University
Xi'an, Shaanxi, China