Clinical trial · Interventional
Orelabrutinib in the Treatment of HP-positive Gastric MALT Lymphoma
Orelabrutinib in the First-line Treatment of HP-positive Gastric MALT Lymphoma: a Multicenter, Open-label, Randomized Controlled Trial
NCT06228963CI-TRIAL-00074290recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Describe the efficacy and safety of Orelabrutinib in the treatment of HP-positive gastric MALT lymphoma
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Helicobacter Pylori Infection | — | UNRESOLVED | — |
| MALT Lymphoma of Stomach | Gastric Mucosa-Associated Lymphoid Tissue Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Triple therapy for eradication of Helicobacter Pylori | Drug | — | UNRESOLVED |
| Triple therapy for eradication of Helicobacter Pylori and Orelabrutinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental group
- description
- Triple therapy for eradication of Helicobacter Pylori+Orelabrutinib
- interventionNames
- Drug: Triple therapy for eradication of Helicobacter Pylori and Orelabrutinib
- type
- ACTIVE_COMPARATOR
- label
- Control group
- description
- Triple therapy for eradication of Helicobacter Pylori
- interventionNames
- Drug: Triple therapy for eradication of Helicobacter Pylori
Primary outcomes (1)
- measure
- 6-months CR rate
- timeFrame
- up to 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.