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Recruiting Phase 2

Orelabrutinib in the Treatment of HP-positive Gastric MALT Lymphoma

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About this study

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

Condition
MALT Lymphoma of Stomach, Helicobacter Pylori Infection
Tested
Triple therapy for eradication of Helicobacter Pylori and Orelabrutinib, Triple therapy for eradication of Helicobacter...
Sponsor
Fudan University

Who can join

Age
18 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 10

  • Minimum age: 18 years
  • Study condition: MALT Lymphoma of Stomach, Helicobacter Pylori Infection
  • 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 7

  • 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

1 site, 1 recruiting

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.