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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)

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
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04365036
Enrollment
207
Registered
2020-04-28
Start date
2020-05-03
Completion date
2028-12-31
Last updated
2025-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NK/T Cell Lymphoma Nos

Brief 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)

Interventions

DRUGToripalimab

toripalimab 240mg, d1, intravenous drip

DRUGPegaspargase

pegaspargase, 2000U/m2, d1, intravenous drip

DRUGGemcitabine

gemcitabine, 1000mg/m2, d1,d8, intravenous drip

DRUGOxaliplatin

oxaliplatin, 130mg/m2, d1, intravenous drip,

RADIATIONDefinitive intensity-modulated radiotherapy (IMRT)

Definitive intensity-modulated radiotherapy (IMRT) of 54-56Gy will be given in 25\ 26 days

Sponsors

Sun Yat-sen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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；

Design outcomes

Primary

MeasureTime frame
progression free survival (PFS)3 years

Secondary

MeasureTime frame
overall response rate (ORR)From the start of treatment with the interventions until 6 months
overall survival (OS)3 years
complete remission (CR) rateFrom the start of treatment with the interventions until 6 months
event free survival (EFS)3 years
disease-free survival (DFS)3 years
recurrence-free survival (RFS)3 years

Countries

China

Contacts

Primary ContactQingqing Cai, MD
caiqq@sysucc.org.cn0086-20-87342823

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026