RECRUITINGPhase 2INTERVENTIONAL
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
About This Trial
Describe the efficacy and safety of Orelabrutinib in the treatment of HP-positive gastric MALT lymphoma
Who May Be Eligible (Plain English)
Who May Qualify:
- Age ≥ 18 years old
- diagnosed by tissue sample (biopsy-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 willing to sign a consent form form.
- Evaluable lesions present.
Who Should NOT Join This Trial:
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
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)
Locations (1)
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China