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)
1 other identifier
interventional
207
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2020
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2020
CompletedFirst Posted
Study publicly available on registry
April 28, 2020
CompletedStudy Start
First participant enrolled
May 3, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
March 13, 2025
March 1, 2025
8.7 years
April 24, 2020
March 11, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
progression free survival (PFS)
3 years
Secondary Outcomes (6)
complete remission (CR) rate
From the start of treatment with the interventions until 6 months
overall response rate (ORR)
From the start of treatment with the interventions until 6 months
overall survival (OS)
3 years
recurrence-free survival (RFS)
3 years
event free survival (EFS)
3 years
- +1 more secondary outcomes
Study Arms (2)
toripalimab with P-GemOx
EXPERIMENTALPatients will receive toripalimab and induction chemotherapy with pegaspargase, gemcitabine, oxaliplatin, every 3 weeks for 4 cycles before radiation. Definitive intensity-modulated radiotherapy (IMRT) will be given. Concurrent toripalimab of 240mg will be administered every 3 weeks for 3 cycles during IMRT. Toripalimab 240mg will be given every 3 weeks for 13 cycles, started on day 1 of induction chemotherapy.
P-GemOx
ACTIVE COMPARATORPatients will receive induction chemotherapy with pegaspargase, gemcitabine, oxaliplatin, every 3 weeks for 4 cycles before radiation. Definitive intensity-modulated radiotherapy (IMRT) will be given.
Interventions
Definitive intensity-modulated radiotherapy (IMRT) of 54-56Gy will be given in 25\~26 days
Eligibility Criteria
You may qualify if:
- 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;
- years; without other malignancy;
- proper functioning of the major organs.
You may not qualify if:
- hemophagocytic syndrome or aggressive NK cell leukemia;
- involvement of central nervous system;
- previously received treatment of chemotherapy, radiotherapy, immunotherapy or biotherapy for lymphoma；
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Guangdong General Hospital
Guangzhou, Guangdong, 510000, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief physician
Study Record Dates
First Submitted
April 24, 2020
First Posted
April 28, 2020
Study Start
May 3, 2020
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
March 13, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share