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Orelabrutinib in the Treatment of HP-positive Gastric MALT Lymphoma

NCT06228963 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2024-02-23

No results posted yet for this study

Summary

Describe the efficacy and safety of Orelabrutinib in the treatment of HP-positive gastric MALT lymphoma

Conditions

  • MALT Lymphoma of Stomach
  • Helicobacter Pylori Infection

Interventions

DRUG

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)

DRUG

Triple therapy for eradication of Helicobacter Pylori

Triple therapy for H. pylori (oral administration for 2 weeks, followed by a 1-week break)

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Yizhen Liu, M.D., Ph.D. · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-31
Primary Completion
2026-01-31
Completion
2028-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06228963 on ClinicalTrials.gov