Mucosa-Associated Lymphoid Tissue (MALT) Lymphoma
Conditions
Interventions
Experimental group:Vonoprazan fumarate: 20mg twice a day
combined with amoxicillin: 4 capsules three times a day. Take the above medications for 10 days.
Sponsors
Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. According to the 2016 WHO classification of hematopoietic and lymphoid tissue tumors, a histopathologically confirmed diagnosis of extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue (MALT) limited to the stomach and surrounding lymphoid tissues; 2. Age >=18 years and =30 mL/min; (3) Coagulation function: international normalized ratio (INR) and prothrombin time (PT) <=1.5 × ULN. Note: For patients who do not meet the above criteria, supportive treatment is allowed, and the investigator will determine whether they are suitable for enrollment; 8. Patients are informed and voluntarily agree to participate in this study and are able to comply with the visit schedule and related procedures specified in the protocol.
Exclusion criteria
Exclusion criteria: 1. Patients who, in the investigator's judgment, are allergic, resistant, or intolerant to any of the drugs in the treatment regimen; 2. Patients who have received any investigational drugs or radiotherapy within the past 4 weeks; 3. Patients who have undergone major surgery within the past 4 weeks; 4. Patients with severe infections within the past 4 weeks who, in the investigator's judgment, are not suitable for chemotherapy; 5. Patients with a history of stroke or intracranial hemorrhage within the past 3 months; or those with active grade 3 or higher gastrointestinal bleeding; 6. Women who are pregnant or breastfeeding; 7. Patients with impaired cardiac function or significant heart disease, including but not limited to: (1) Myocardial infarction, congestive heart failure, or viral myocarditis within the 6 months prior to screening; (2) Cardiac diseases requiring treatment intervention, such as unstable angina or arrhythmias; (3) NYHA class II-IV heart function; (4) Echocardiographic left ventricular ejection fraction (EF) below 50% or below the center's lower limit; 8. Patients with a known history of human immunodeficiency virus (HIV) infection, primary immunodeficiency, or active pulmonary tuberculosis; 9. Patients with poorly controlled hypertension or diabetes; 10. Patients with a history of malignancy that may affect the implementation or outcome analysis of the trial (except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, carcinoma in situ of gastrointestinal mucosa, or localized prostate cancer); 11. Patients with active psychiatric disorders, alcoholism, drug abuse, or substance abuse; 12. Patients deemed unsuitable for participation in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Helicobacter pylori eradication rate at 6 weeks after completion of anti-Helicobacter pylori therapy.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety; | — |
Countries
China
Contacts
Public ContactLei Fan
Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University
Outcome results
None listed