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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Triple therapy for eradication of Helicobacter Pylori+Orelabrutinib |
|
| Control group | Active Comparator | Triple therapy for eradication of Helicobacter Pylori |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triple therapy for eradication of Helicobacter Pylori and Orelabrutinib | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 6-months CR rate | the ratio of numbers of patients with complete response to all the participants receiving treatment | up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 3-months CR rate | the ratio of numbers of patients with complete response to all the participants | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory biomarkers | Biomarkers for predictive factors of efficacy at baseline or during the treatment | Throughout the treatment period, up to 2 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yizhen Liu, M.D., Ph.D. | Contact | 021-64175590 | 85100 | aliuyz@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yizhen Liu, M.D., Ph.D. | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| C000729508 | orelabrutinib |
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| Triple therapy for eradication of Helicobacter Pylori | Drug | Triple therapy for H. pylori (oral administration for 2 weeks, followed by a 1-week break) |
|
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| 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 | 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 | 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 | Throughout the treatment period, up to 6 months |