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This study is intend to improve the objective response rate in treatment of camrelizumab in recurrent primary central nervous system lymphoma patients.
Primary CNS lymphoma (PCNSL) is a rare B-cell variant of non-Hodgkin lymphoma that is confined to the brain, leptomeninges, spinal cord, and eyes. The optimum treatment for patients with recurrent PCNSL remains challenging and at present there is no universally accepted therapeutic approach . The purpose of this study is to evaluate the efficacy and safety of camrelizumab [a programmed cell death 1 (PD-1) inhibitor] for recurrent patients with primary CNS lymphoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Camrelizumab | Experimental | Camrelizumab(SHR-1210) 200mg, once every 2 weeks, each 4 weeks is 1cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab | Drug | Camrelizumab(SHR-1210) 200mg, once every 2 weeks, each 4 weeks is 1cycle. |
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| Measure | Description | Time Frame |
|---|---|---|
| ORR(objective response rate) | the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period | Up to three years |
| Measure | Description | Time Frame |
|---|---|---|
| The best therapeutic response of CR(complete response)、PR(partial response)、SD(stable response) and PD(progressive disease) | Describe the best therapeutic response of patients treated with Camrelizumab | Up to three years |
| PFS(progression free survival) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanbo Brain Hospital Capital Medical University | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
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the time from randomization until objective tumor progression or death |
| Up to three years |
| OS(overall survival) | the time from randomization until death from any cause and is measured in the intent-to-treat population | Up to three years |
| ADEs( adverse events) | Adverse events at each visit with the NCI CTCAE v5.0 used as a guide for the grading of severity. | Up to three years |
| KPS(Karnofsky Performance Status) | Duration of stabilization/improvement of Karnofsky Performance Status | Up to three years |