MALT Lymphoma of StomachHelicobacter Pylori Infection
Investigational drug(s) / intervention(s)
Triple therapy for eradication of Helicobacter Pylori and OrelabrutinibTriple therapy for eradication of Helicobacter Pylori
Triple therapy for eradication of Helicobacter Pylori and Orelabrutinib: Triple therapy for H. pylori (oral administration for 2 weeks, followed by a 1-week break) plus Orelabrutinib for 8 weeks (or until progression, intolerable toxicity, death, or withdrawal from the study)
Triple therapy for eradication of Helicobacter Pylori: Triple therapy for H. pylori (oral administration for 2 weeks, followed by a 1-week break)
Study summary
Describe the efficacy and safety of Orelabrutinib in the treatment of HP-positive gastric MALT lymphoma
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Age ≥ 18 years old
* Histologically confirmed gastric mucosa-associated lymphoid tissue (MALT) lymphoma;
* Current infection with Helicobacter pylori (Hp): Diagnosis can be made if any of the following criteria are met: a) Positive result in at least one of the following: RUT (rapid urease test), histological staining, or bacterial culture of gastric mucosal tissue; b) Positive result in 13C or 14C-UBT (urea breath test); c) Positive result in HpSA detection. A positive result in serum Hp antibody test indicates past infection, and patients who have never been treated can be considered as having current infection.
* ECOG (Eastern Cooperative Oncology Group) performance status 0-2.
* Lugano staging I-II1.
* Signed informed consent form.
* Evaluable lesions present.
Exclusion Criteria:
* Negative for Helicobacter pylori (HP);
* History of other tumors, except for cured cervical cancer or basal cell carcinoma of the skin;
* Patients with active HIV and syphilis infections;
* Pregnant or lactating women;
* Patients with severe active infections;
* Patients with multiple factors affecting oral medication (such as dysphagia, nausea, vomiting, chronic diarrhea, and intestinal obstruction);
* Other comorbidities or conditions that may prevent patients from completing the clinical trial.
Primary outcome measure(s)
6-months CR rate — up to 6 months the ratio of numbers of patients with complete response to all the participants receiving treatment
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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