gastric cancer
Conditions
Interventions
control group:standard postoperative chemotherapy
experimental group:Helicobacter pylori eradication therapy combined with standard postoperative chemotherapy
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. To have fully informed consent and sign a written consent form approved by the IRB/IEC; 2. To have good compliance and be willing and able to follow the scheduled follow-up, treatment plan, laboratory tests, and other requirements of the study; 3. To have a pathological diagnosis of gastric adenocarcinoma and undergo D2 gastrectomy, with postoperative pathology confirming stage II or III (according to the 8th edition of AJCC) gastric cancer; 4. Within 2-4 weeks after surgery, Helicobacter pylori infection is confirmed by routine staining of gastric mucosa (HE staining), rapid urease test, or serum H. pylori antibody detection; 5. The subject must undergo R0 resection, with negative margins in the surgical specimens; 6. Gastric cancer radical surgery must be completed within 4-12 weeks before randomization; 7. No liver, peritoneal, retroperitoneal lymph node, or other distant metastases; 8. Overall health status is good, with an ECOG score of 0-1; 9. No gender restrictions, ages 18-75 years old; 10. Expected survival time is greater than 3 months; 11. Laboratory test values must meet the following criteria within 14 days before enrollment: • WBC > 4.0×109/L and 1.5×109/L, PLT = 100×109/L; • Serum bilirubin = 1.5× upper limit of normal (ULN), AST and ALT = 2.5× ULN; • Creatinine = 1.5× ULN or serum clearance rate > 60 ml/min, according to the Cockcroft-Gault estimated glomerular filtration rate: (140 - age) × (body weight in kg) × (0.85 for females)/[72 × (serum creatinine in mg/dL)]; • INR and APTT = 1.5 × ULN, applicable only to subjects who have not received anticoagulant therapy; those receiving anticoagulant therapy should use stable doses.
Exclusion criteria
Exclusion criteria: 1. Patients with recurrent gastric cancer or previous gastric surgery; 2. Patients who received neoadjuvant chemotherapy before radical gastrectomy for gastric cancer; 3. Patients with a history of or currently suffering from other malignant tumors, except those who achieved complete remission at least 5 years before the start of the study and do not require additional treatment during the study period (such as stage I squamous cell carcinoma, in situ carcinoma, mucosal carcinoma, superficial bladder cancer, non-melanoma skin cancer, etc.); 4. Patients allergic to the drug components of this protocol; 5. Any other clinically significant disease or condition that the investigator believes may affect compliance with the protocol, affect the subject's ability to sign the informed consent form (ICF), or make them unsuitable for participation in this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| recurrence-free survival (RFS);recurrence rate of Helicobacter pylori infection; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival (OS);safety;the initial eradication rate of Helicobacter pylori; | — |
Countries
China
Contacts
Public ContactYingbo Chen
Sun Yat-Sen University Cancer Center
Outcome results
None listed