A Multicenter, Phase 3, Randomized Trial of Sequencial Chemoradiotherapy With or Without Toripalimab (PD-1 Antibody) in Newly Diagnosed Early-Stage Extranodal Natural Killer/T Cell Lymphoma, Nasal Type (ENKTL)

Study Overview
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Brief Summary
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The purpose of this randomized, multi-center,phase Ⅲ 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)

Official Title
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A Multicenter, Phase 3, Randomized Trial of Sequencial Chemoradiotherapy With or Without Toripalimab (PD-1 Antibody) in Newly Diagnosed Early-Stage Extranodal Natural Killer/T Cell Lymphoma, Nasal Type (ENKTL)

Conditions
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NK/T Cell Lymphoma Nos

Intervention / Treatment
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* Drug: Toripalimab
* Drug: Pegaspargase
* Drug: Gemcitabine
* Drug: Oxaliplatin
* Radiation: Definitive intensity-modulated radiotherapy (IMRT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: biopsy proved extranodal natural killer/T-cell lymphoma, nasal type; newly diagnosed stage I/II patients; at least one evaluable lesion； ECOG PS 0-2; 18-75 years; without other malignancy; proper functioning of the major organs. Exclusion Criteria: hemophagocytic syndrome or aggressive NK cell leukemia; involvement of central nervous system; previously received treatment of chemotherapy, radiotherapy, immunotherapy or - biotherapy for lymphoma；

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: toripalimab with P-GemOx<br>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. | Drug: Toripalimab<br>* toripalimab 240mg, d1, intravenous drip<br>Drug: Pegaspargase<br>* pegaspargase, 2000U/m2, d1, intravenous drip<br>Drug: Gemcitabine<br>* gemcitabine, 1000mg/m2, d1,d8, intravenous drip<br>Drug: Oxaliplatin<br>* oxaliplatin, 130mg/m2, d1, intravenous drip,<br>Radiation: Definitive intensity-modulated radiotherapy (IMRT)<br>* Definitive intensity-modulated radiotherapy (IMRT) of 54-56Gy will be given in 25 26 days<br>|
| Active Comparator: P-GemOx<br>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. | Drug: Pegaspargase<br>* pegaspargase, 2000U/m2, d1, intravenous drip<br>Drug: Gemcitabine<br>* gemcitabine, 1000mg/m2, d1,d8, intravenous drip<br>Drug: Oxaliplatin<br>* oxaliplatin, 130mg/m2, d1, intravenous drip,<br>Radiation: Definitive intensity-modulated radiotherapy (IMRT)<br>* Definitive intensity-modulated radiotherapy (IMRT) of 54-56Gy will be given in 25 26 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival (PFS) |  | 3-years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete remission (CR) rate |  | 1-years | 
| overall response rate (ORR) |  | 1-years | 
| overall survival (OS) |  | 3-years | 
| recurrence-free survival (RFS) |  | 3-years | 
| event free survival (EFS) |  | 3-years | 
| disease-free survival (DFS) |  | 3-years |