NCT06510010

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.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 198 (estimated)
• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Subjects randomized to the trial group will receive 3-4 cycles of oxaliplatin with S-1 (SOX)+ H. pylori eradication (a 14-day quadruple regimen: amoxicillin + clarithromycin + omeprazole + bismuth potassium citrate) before surgery. One of the SOX regimens will be every 3 weeks (Q3W), with a tumor response assessment at the end of the neoadjuvant therapy course. Patients will continue to receive 4-5 cycles of SOX adjuvant chemotherapy after surgery for a total of 8 cycles of SOX regimen treatment. Patients in the trial group will undergo H. pylori eradication at the time of the first cycle of the SOX regimen. H. pylori eradication will be determined by postoperative pathology, and those who are H. pylori-positive by postoperative pathology will be treated with remedial eradication therapy after recovery from surgery (except for patients with total gastric resection). Subjects randomized to the control group will receive 3-4 cycles of neoadjuvant therapy with the SOX regimen before surgery. The SOX regimen will be administered every 3 weeks (Q3W). A tumor response assessment will be performed at the end of the treatment course. Control patients were treated with H. pylori eradication after recovery from surgery based on postoperative pathologic H. pylori results: if H. pylori-positive, they received H. pylori eradication plus 4-5 cycles of SOX adjuvant chemotherapy (except for patients who underwent total gastric resection); if H. pylori-negative, they received 4-5 cycles of SOX adjuvant chemotherapy only.

Conditions

• Chemotherapy Effect

Interventions

Type	Name	Description
DRUG	Oxaliplatin 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.
DRUG	Oxaliplatin 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.

Timeline

• Start date: 2024-12-31
• Primary completion: 2026-12-28
• Completion: 2027-07-31
• First posted: 2024-07-19
• Last updated: 2026-01-26

Locations

1 site across 1 country: China