NCT06228963 Orelabrutinib in the Treatment of HP-positive Gastric MALT Lymphoma
| NCT ID | NCT06228963 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Fudan University |
| Condition | MALT Lymphoma of Stomach |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2024-03 |
| Primary Completion | 2026-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 160 participants in total. It began in 2024-03 with a primary completion date of 2026-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Describe the efficacy and safety of Orelabrutinib in the treatment of HP-positive gastric MALT lymphoma
Eligibility Criteria
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.
Contact & Investigator
Yizhen Liu, M.D., Ph.D.
PRINCIPAL INVESTIGATOR
Fudan University
Frequently Asked Questions
Who can join the NCT06228963 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying MALT Lymphoma of Stomach. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06228963 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06228963 currently recruiting?
Yes, NCT06228963 is actively recruiting participants. Contact the research team at aliuyz@126.com for enrollment information.
Where is the NCT06228963 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06228963 clinical trial?
NCT06228963 is sponsored by Fudan University. The principal investigator is Yizhen Liu, M.D., Ph.D. at Fudan University. The trial plans to enroll 160 participants.