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The purpose of this randomized, multi-center,phase â…¢ clinical trail is to compare the safety and efficacy of sequencial chemoradiotherapy with or without toripalimab (PD-1 antibody) for newly diagnosed early-stage extranodal natural killer/T-cell lymphoma, nasal type (ENKTL)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| toripalimab with P-GemOx | Experimental | Patients will receive toripalimab and induction chemotherapy with pegaspargase, gemcitabine, oxaliplatin, every 3 weeks for 4 cycles before radiation. Definitive intensity-modulated radiotherapy (IMRT) will be given. Concurrent toripalimab of 240mg will be administered every 3 weeks for 3 cycles during IMRT. Toripalimab 240mg will be given every 3 weeks for 13 cycles, started on day 1 of induction chemotherapy. |
|
| P-GemOx | Active Comparator | Patients will receive induction chemotherapy with pegaspargase, gemcitabine, oxaliplatin, every 3 weeks for 4 cycles before radiation. Definitive intensity-modulated radiotherapy (IMRT) will be given. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toripalimab | Drug | toripalimab 240mg, d1, intravenous drip |
| |
| Measure | Description | Time Frame |
|---|---|---|
| progression free survival (PFS) | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| complete remission (CR) rate | From the start of treatment with the interventions until 6 months | |
| overall response rate (ORR) | From the start of treatment with the interventions until 6 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qingqing Cai, MD | Contact | 0086-20-87342823 | caiqq@sysucc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong General Hospital | Recruiting | Guangzhou | Guangdong | 510000 | China |
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| Pegaspargase |
| Drug |
pegaspargase, 2000U/m2, d1, intravenous drip |
|
| Gemcitabine | Drug | gemcitabine, 1000mg/m2, d1,d8, intravenous drip |
|
| Oxaliplatin | Drug | oxaliplatin, 130mg/m2, d1, intravenous drip, |
|
| Definitive intensity-modulated radiotherapy (IMRT) | Radiation | Definitive intensity-modulated radiotherapy (IMRT) of 54-56Gy will be given in 25~26 days |
|
| overall survival (OS) |
| 3 years |
| recurrence-free survival (RFS) | 3 years |
| event free survival (EFS) | 3 years |
| disease-free survival (DFS) | 3 years |
| ID | Term |
|---|---|
| C000656314 | toripalimab |
| C042705 | pegaspargase |
| D000093542 | Gemcitabine |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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