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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

NCT07751302 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2026-08-07

No results posted yet for this study

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.

Conditions

  • Stage IB-IIA Adenocarcinoma of the Stomach or Gastroesophageal Junction

Interventions

DRUG

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.

Sponsors & Collaborators

  • Xijing Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-10
Primary Completion
2036-01-31
Completion
2036-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07751302 on ClinicalTrials.gov