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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
207
toripalimab 240mg, d1, intravenous drip
pegaspargase, 2000U/m2, d1, intravenous drip
gemcitabine, 1000mg/m2, d1,d8, intravenous drip
oxaliplatin, 130mg/m2, d1, intravenous drip,
Definitive intensity-modulated radiotherapy (IMRT) of 54-56Gy will be given in 25\~26 days
Guangdong General Hospital
Guangzhou, Guangdong, China
RECRUITINGprogression free survival (PFS)
Time frame: 3 years
complete remission (CR) rate
Time frame: From the start of treatment with the interventions until 6 months
overall response rate (ORR)
Time frame: From the start of treatment with the interventions until 6 months
overall survival (OS)
Time frame: 3 years
recurrence-free survival (RFS)
Time frame: 3 years
event free survival (EFS)
Time frame: 3 years
disease-free survival (DFS)
Time frame: 3 years
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