Overview
Describe the efficacy and safety of Orelabrutinib in the treatment of HP-positive gastric MALT lymphoma
Description
This multicenter, open-label, randomized controlled trial is trying to evaluate the efficacy and safety of Orelabrutinib in the first-line treatment of HP-positive gastric MALT lymphoma
Eligibility
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.