Describe the efficacy and safety of Orelabrutinib in the treatment of HP-positive gastric MALT lymphoma
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
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)
Triple therapy for H. pylori (oral administration for 2 weeks, followed by a 1-week break)
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITING6-months CR rate
the ratio of numbers of patients with complete response to all the participants receiving treatment
Time frame: up to 6 months
3-months CR rate
the ratio of numbers of patients with complete response to all the participants
Time frame: up to 3 months
2-year progression-free survival (PFS)
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
Time frame: 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
2-year event-free survival (EFS)
the period from the date of patients sign informed consent to the observed event for any reason
Time frame: 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
2-year overall survival rate
time between the date of patients sign informed consent and the date of death or the date of last follow-up time
Time frame: 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
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Record the name of adverse events and number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Throughout the treatment period, up to 6 months
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