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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)

NCT04365036 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 207

Last updated 2025-03-13

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-03
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04365036 on ClinicalTrials.gov