Gastric adenocarcinoma
Conditions
Interventions
Treatment group:Eradication of HP while receiving palliative comprehensive treatment
Control group:Receiving palliative comprehensive treatment only
Sponsors
The First Affiliated Hospital,Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Patients with advanced gastric cancer diagnosed as unresectable or metastatic by pathology and imaging (stage IV, according to AJCC 8th Edition); 2.HP infection was confirmed by rapid urease test, 13C or 14C urea breath test, or histopathological examination; 3.Aged between 18 and 75, able to understand and sign the informed consent form; 4.Plan to accept standard palliative comprehensive treatment (such as chemotherapy, targeted therapy, immunotherapy, etc.); 5.The ECoG score was 0-1; 6.Expected survival time >= 3 months; 7.The researcher judged that he could abide by the research protocol; 8.The baseline blood routine and life indicators of selected patients should meet the following criteria: a. Hemoglobin >= 90g/L, in order to meet this standard, patients can receive blood transfusion treatment; b. Absolute neutrophil count >= 1.5x10^9/l; c. Platelet count >= 100x10^9/l; d. Aspartate or alanine aminotransferase <= 2.5 times the upper limit; e. Alkaline phosphatase <= 2.5 times the upper limit of normal (ULN); f. Thyroid stimulating hormone (TSH) <= 1-fold ULN (if abnormal, T3 and T4 levels should be examined at the same time. If T3 and T4 levels are normal, they can be included in the group).
Exclusion criteria
Exclusion criteria: 1.Patients with recurrent gastric cancer or patients who have undergone gastric surgery; 2.Previous systemic treatment for gastric cancer; 3.Patients has received HP radical treatment in the past; 4.Serious cardiovascular disease, liver and kidney dysfunction, uncontrolled diabetes or other serious comorbidities that affect the results of the study; 5.Pregnant or lactating women; 6.Allergic to drugs used in HP radical treatment (amoxicillin, clarithromycin, proton pump inhibitor and bismuth potassium citrate); 7.Participated in other intervention clinical trials in the past 30 days; 8.Mental or cognitive impairment, unable to understand or cooperate with the research; 9.Patients who have difficulty in eating and cannot take oral drugs;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate;Initial eradication rate of Helicobacter pylori;Objective Response Rate;Overall Survival;Incidence of complications;Symptom relief;Quality of Life; | — |
Countries
China
Contacts
Public Contactshirongcai
The First Affiliated Hospital,Sun Yat-sen University
Outcome results
None listed