RecruitingPhase 2NCT06510010

Perioperative Oxaliplatin With S-1 Combined H. Pylori Eradication in the Management of Locally Advanced Gastric Cancer

Perioperative Oxaliplatin With S-1 Combined H. Pylori Eradication in the Management of Locally Advanced Adenocarcinoma of the Gastric and Oesophagogastric Junction: an Open-label, Prospective, Multicenter, Randomised, Phase 2 Trial.

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Enrollment

198 participants

Start Date

Dec 31, 2024

Study Type

INTERVENTIONAL

Conditions

Chemotherapy Effect

Summary

This study focuses on patients with H. pylori-positive resectable locally advanced adenocarcinoma of the gastric and oesophagogastric junction. It evaluates the perioperative oxaliplatin with S-1 (SOX) combined H. pylori eradication versus oxaliplatin with S-1 in the management of H. pylori-positive locally advanced adenocarcinoma of the gastric and oesophagogastric junction (cT3/4a Nx or T2 N2/3, M0) , assessing their values and advantages.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding H. pylori eradication (antibiotic treatment to eliminate the H. pylori stomach bacteria) to standard perioperative chemotherapy (oxaliplatin with S-1) improves outcomes for patients with locally advanced stomach or stomach-junction cancer who are H. pylori positive. **You may be eligible if...** - You have been diagnosed with locally advanced adenocarcinoma of the stomach or esophagogastric junction (confirmed by gastroscopy) - Your cancer is at a surgically appropriate stage (cT3/4a or T2 with significant lymph node involvement, without distant spread) - You currently have an active H. pylori infection confirmed by testing - You are fit enough to undergo surgery and chemotherapy **You may NOT be eligible if...** - Your cancer has spread to distant organs (metastatic) - You do not have H. pylori infection - You have serious heart, liver, kidney, or other organ problems that prevent chemotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOxaliplatin With S-1 (SOX) Combined H. Pylori Eradication (Amoxicillin + clarithromycin + omeprazole + colloidal bismuth subcitrate)

Oxaliplatin With S-1 (SOX) regimen: S-1: 40mg/m2, oral, bid, D1-14, one cycle every 3 weeks; Oxaliplatin: 130 mg/m2, IV, qd, D1, every 3 weeks for one cycle. H. pylori eradication regimen: H. pylori eradication was performed using a quadruple regimen for 14 d. Omeprazole 20 mg bid+Colloidal bismuth subcitrate 220mg bid+Amoxicillin 1g bid+Clarithromycin 500mg bid.

DRUGOxaliplatin With S-1 （SOX）

Oxaliplatin With S-1 （SOX） regimen: S-1: 40mg/m2, oral, bid, D1-14, one cycle every 3 weeks; Oxaliplatin: 130 mg/m2, IV, qd, D1, every 3 weeks for one cycle.