Treatment of HP-positive gastric MALT lymphoma with Orelabrutinib

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, open-label, randomized controlled trial evaluates the efficacy and safety of Orelabrutinib in patients with HP-positive gastric MALT lymphoma. Participants will receive a combination of triple therapy for Helicobacter pylori eradication along with Orelabrutinib as a first-line treatment. The study aims to determine how well this treatment works compared to standard approaches. Patients will be monitored for both effectiveness and safety throughout the trial.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Yizhen Liu, M.D., Ph.D. — Fudan University
• Study coordinator: Yizhen Liu, M.D., Ph.D.
• Email: aliuyz@126.com
• Phone: 021-64175590

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Ultra-low-dose radiation followed by orelabrutinib for early-stage MALT lymphoma

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.