Helicobacter Pylori Infection, MALT Lymphoma of Stomach
Conditions
Brief summary
Describe the efficacy and safety of Orelabrutinib in the treatment of HP-positive gastric MALT lymphoma
Detailed description
This multicenter, open-label, randomized controlled trial is trying to evaluate the efficacy and safety of Orelabrutinib in the first-line treatment of HP-positive gastric MALT lymphoma
Interventions
DRUGTriple 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)
DRUGTriple therapy for eradication of Helicobacter Pylori
Triple therapy for H. pylori (oral administration for 2 weeks, followed by a 1-week break)
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6-months CR rate | up to 6 months | the ratio of numbers of patients with complete response to all the participants receiving treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 3-months CR rate | up to 3 months | the ratio of numbers of patients with complete response to all the participants |
| 2-year progression-free survival (PFS) | From date of patients sign informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years | the period from the date of patients sign informed consent to the observed progression of the disease or the occurrence of death for any reason |
| 2-year overall survival rate | From date of patients sign informed consent until the date of death or the date of last follow-up time, whichever came first, assessed up to 2 years | time between the date of patients sign informed consent and the date of death or the date of last follow-up time |
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | Throughout the treatment period, up to 6 months | Record the name of adverse events and number of participants with treatment-related adverse events as assessed by CTCAE v5.0 |
| 2-year event-free survival (EFS) | From date of patients sign informed consent until the date of first documented event, progression or date of death from any cause, whichever came first, assessed up to 2 years | the period from the date of patients sign informed consent to the observed event for any reason |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploratory biomarkers | Throughout the treatment period, up to 2 years | Biomarkers for predictive factors of efficacy at baseline or during the treatment |
Countries
China
Contacts
Primary ContactYizhen Liu, M.D., Ph.D.
Outcome results
None listed