Overview

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
Trial end date:
2025-06-01
Target enrollment:
0
Participant gender:
All
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)
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sun Yat-sen University
Treatments:
Gemcitabine
Oxaliplatin
Pegaspargase
Criteria
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;