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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)
Sponsor: Sun Yat-sen University
Summary
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)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
207
Start Date
2020-05-03
Completion Date
2028-12-31
Last Updated
2025-03-13
Healthy Volunteers
No
Conditions
Interventions
Toripalimab
toripalimab 240mg, d1, intravenous drip
Pegaspargase
pegaspargase, 2000U/m2, d1, intravenous drip
Gemcitabine
gemcitabine, 1000mg/m2, d1,d8, intravenous drip
Oxaliplatin
oxaliplatin, 130mg/m2, d1, intravenous drip,
Definitive intensity-modulated radiotherapy (IMRT)
Definitive intensity-modulated radiotherapy (IMRT) of 54-56Gy will be given in 25\~26 days
Locations (1)
Guangdong General Hospital
Guangzhou, Guangdong, China