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.
have been fully informed about the study and voluntarily signed the informed consent form (ICF);
Gastroscopy pathology confirmed locally advanced adenocarcinoma of the gastric and oesophagogastric junction (Siewert type I-III);
The present H. Pylori infection at the time of diagnosis is determined by one of the following 3 items: ① Positive gastric mucosal tissue rapid urease test (RUT), tissue section staining, or bacterial culture for any of the 3 items. Positive 13C or 14C-urea breath test (UBT). ③ Positive helicobacter pylori stool antigen (HpSA) tests (clinically validated monoclonal antibody method). Positive serum H. Pylori antibody test (clinically proven reagent with high accuracy) suggests previous infection, and those who have never been treated can be considered as having current infection;
Sex is not limited and age is 18-75 years old;
Stage IV or unresectable gastric or gastroesophageal junction cancer as determined by the investigator;
Other active malignancies within 5 years or concurrently.
Patients who are preparing for or have previously received organ or bone marrow transplantation;
Myocardial infarction, poorly controlled arrhythmia (including QTc interval ≥ 450 ms in men and ≥ 470 ms in women) within 6 months prior to the first dose (QTc interval is calculated by the Fridericia formula);
Parallel
Oxaliplatin With S-1 (SOX) Combined H. Pylori Eradication (Amoxicillin + clarithromycin + omeprazole + colloidal bismuth subcitrate)
DrugOxaliplatin 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.
Oxaliplatin With S-1 （SOX）
DrugOxaliplatin 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.
major pathological response (MPR)
MPR defined as a tumor regression grade (TRG) score of 0-1; TRG 0 represents complete remission (no residual cancer cells), TRG 1 meant significant remission (residual lesions \< 10%)
pathological complete response (pCR)
pCR defined as tumor regression grade (TRG) score of 0；TRG 0 represents complete remission (no residual cancer cells)
overall survival （OS）
Overall survival （OS） refers to the time from the beginning of randomization to death from any cause.
disease-free survival (DFS)
Disease-free survival (DFS) refers to the time from the beginning of randomization to the recurrence of the disease or death from any cause (whichever occurs first).
adverse events (AE)
Adverse events (AE) means all adverse medical events that occur after the subject has received the experimental medication.
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