NCT04365036

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 207 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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)

Conditions

• NK/T Cell Lymphoma Nos

Interventions

Type	Name	Description
DRUG	Toripalimab	toripalimab 240mg, d1, intravenous drip
DRUG	Pegaspargase	pegaspargase, 2000U/m2, d1, intravenous drip
DRUG	Gemcitabine	gemcitabine, 1000mg/m2, d1,d8, intravenous drip
DRUG	Oxaliplatin	oxaliplatin, 130mg/m2, d1, intravenous drip,
RADIATION	Definitive intensity-modulated radiotherapy (IMRT)	Definitive intensity-modulated radiotherapy (IMRT) of 54-56Gy will be given in 25\~26 days

Timeline

• Start date: 2020-05-03
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2020-04-28
• Last updated: 2025-03-13

Locations

1 site across 1 country: China