Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT06510010

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

Led by Sixth Affiliated Hospital, Sun Yat-sen University · Updated on 2026-01-26

198

Participants Needed

1

Research Sites

134 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Fully informed and voluntarily signed informed consent
  • Diagnosed with locally advanced adenocarcinoma of the stomach or gastroesophageal junction confirmed by gastroscopy pathology
  • Clinical staging at diagnosis of cT3/4a Nx or T2 N2/3, M0
  • Confirmed current Helicobacter pylori infection by rapid urease test, tissue staining, bacterial culture, urea breath test, stool antigen test, or serum antibody test (if untreated)
  • Age between 18 and 75 years, any sex
  • Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
  • Organ function suitable for major abdominal surgery
  • Expected survival of at least 6 months
  • Laboratory test results within 7 days before enrollment meet specified blood counts, liver and kidney function, and coagulation parameters
  • Ability to complete required endoscopic, laboratory, and imaging tests
  • Agree to use contraception and avoid breastfeeding as specified if of childbearing potential
Not Eligible

You will not qualify if you...

  • Stage IV or unresectable gastric or gastroesophageal junction cancer
  • Other active cancers within the last 5 years or currently
  • History of organ or bone marrow transplantation or preparing for it
  • Recent myocardial infarction or poorly controlled arrhythmia within 6 months
  • Severe heart failure (NYHA class III-IV) or left ventricular ejection fraction below 50%
  • Active or recent pulmonary tuberculosis
  • Known active or suspected autoimmune disease requiring systemic immunosuppression
  • Received live vaccine within 28 days before first dose, except seasonal influenza vaccine
  • Use of systemic corticosteroids or immunosuppressive drugs above specified doses within 14 days before first dose or during study (with exceptions)
  • Participation in another clinical study with treatment ending less than 14 days before this study
  • History of severe allergies to study drug ingredients
  • History of psychotropic drug abuse or drug addiction
  • Other severe or acute medical conditions judged unsuitable for study participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The Sixth Affiliated Hospital,Sun Yat-sen University

Guangzhou, China

Actively Recruiting

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Research Team

B

Bin Zhong

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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