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The purpose of this multi-center,single arm,phase â…¡ clinical trail is to determine the safety and efficacy of Sintilimab with P-GemOx (pegaspargase, gemcitabine and oxaliplatin) regimen for newly diagnosed advanced extranodal natural killer/T-cell lymphoma, nasal type (ENKTL)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sintilimab With P-GemOx | Experimental | Sintilimab, 200mg, d1, intravenous drip; pegaspargase, 2000U/m2, d1, intravenous drip; gemcitabine, 1000mg/m2, d1,d8, intravenous drip; oxaliplatin, 130mg/m2, d1, intravenous drip; All patients received up to 6 treatment cycles of 21 days. Patients with CR or PR will receive Sintilimab maintenance therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sintilimab,pegaspargase,gemcitabine,oxaliplatin | Drug | All patients enrolled in the study will accept sintilimab with P-GemOx (pegaspargase, gemcitabine and oxaliplatin) regimens their first-line therapy. Patients with CR or PR will receive sintilimab maintenance therapy |
| Measure | Description | Time Frame |
|---|---|---|
| complete remission (CR) rate | 2years | |
| overall response rate (ORR) | 2years |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival (OS) | 2years | |
| progression survival (PFS) | 2years | |
| disease-free survival (DFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University | Guangzhou | Guangdong | 51000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38554717 | Derived | Tian XP, Cai J, Xia Y, Zhang YC, Wang L, Liu PP, Huang HQ, Li YJ, Zhou H, Li ZM, Yang J, Wei LQ, Zou QH, Huang Y, Li J, Ling L, Zhong WL, Cai QQ. First-line sintilimab with pegaspargase, gemcitabine, and oxaliplatin in advanced extranodal natural killer/T cell lymphoma (SPIRIT): a multicentre, single-arm, phase 2 trial. Lancet Haematol. 2024 May;11(5):e336-e344. doi: 10.1016/S2352-3026(24)00066-8. Epub 2024 Mar 27. |
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| ID | Term |
|---|---|
| C000632826 | sintilimab |
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| 2years |
| bio-marker analysis | Correlation between programmed death-ligand 1 expression and efficacy | 2years |