NCT04365036View on ClinicalTrials.gov

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)

PHASE3RecruitingINTERVENTIONAL
Enrollment

207

Participants

Timeline

Start Date

May 3, 2020

Primary Completion Date

December 31, 2028

Study Completion Date

December 31, 2028

Conditions
NK/T Cell Lymphoma Nos
Interventions
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

Trial Locations (1)

510000

RECRUITING

Guangdong General Hospital, Guangzhou

All Listed Sponsors
lead

Sun Yat-sen University

OTHER

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) | Biotech Hunter | Biotech Hunter