Low-dose Aspirin to Prevent Stomach Cancer After Endoscopic Removal of Early Gastric Cancer or High-Grade Adenoma in Adults Aged 19 to 70

What this Trial Is About

Researchers are evaluating the effect of low-dose aspirin 100 mg daily on preventing gastric cancer in patients with early gastric cancer or high-grade adenoma who have undergone endoscopic resection and have a negative or eradicated Helicobacter pylori status. This randomized, placebo-controlled Phase 3 trial addresses limitations in previous studies by focusing specifically on gastric cancer prevention with appropriate sample size and follow-up. Aspirin is commonly used to reduce cardiovascular risks, and some evidence suggests it may also lower gastrointestinal cancer risk, but more targeted research is needed. Participants will be randomly assigned to receive either enteric-coated aspirin 100 mg daily or a placebo tablet for five years. This double-blind study compares the incidence of gastric cancer between the aspirin and placebo groups. The trial includes a treatment period of five years, during which participants take the assigned medication daily. The study also monitors secondary outcomes like mortality, cardiovascular events, occurrence of other cancers, gastric dysplasia, aspirin-related complications, and gastric tissue improvements. During the study, participants will undergo regular assessments including pathology reviews after endoscopic resection and monitoring for adverse events. Researchers will track the primary outcome of gastric cancer incidence throughout the treatment period. Secondary outcomes such as cardiovascular disease rates and overall survival will also be evaluated. The total participant involvement includes screening, a five-year medication period, and ongoing monitoring to assess treatment effects and safety.

Aspirin Use for Gastric Cancer Prevention in the Early Gastric Cancer Patients