Orelabrutinib in the First-line Treatment of HP-positive Gastric MALT Lymphoma: a Multicenter, Open-label, Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Contact Information
Primary
Yizhen Liu, M.D., Ph.D.
aliuyz@126.com
021-64175590
Time Frame
Start Date: 2024-03
Estimated Completion Date: 2028-01
Participants
Target number of participants: 160
Treatments
Experimental: Experimental group
Triple therapy for eradication of Helicobacter Pylori+Orelabrutinib
Active_comparator: Control group
Triple therapy for eradication of Helicobacter Pylori
Sponsors
Leads: Fudan University

This content was sourced from clinicaltrials.gov

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