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)

Phase 3

Recruiting

• Conditions: NK/T Cell Lymphoma Nos
• Interventions: Drug: Toripalimab; Drug: Pegaspargase; Drug: Gemcitabine; Drug: Oxaliplatin; Radiation: Definitive intensity-modulated radiotherapy (IMRT)

• Registration Number: NCT04365036
• Lead Sponsor: Sun Yat-sen University

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-24
• Study First Submitted QC: 2020-04-24
• Study First Posted: 2020-04-28
• Study Start: 2020-05-03
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-13
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 207

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；

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
toripalimab with P-GemOx	Definitive intensity-modulated radiotherapy (IMRT)	Patients 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	Definitive intensity-modulated radiotherapy (IMRT)	Patients will receive induction chemotherapy with pegaspargase, gemcitabine, oxaliplatin, every 3 weeks for 4 cycles before radiation. Definitive intensity-modulated radiotherapy (IMRT) will be given.
toripalimab with P-GemOx	Toripalimab	Patients 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.
toripalimab with P-GemOx	Pegaspargase	Patients 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.
toripalimab with P-GemOx	Gemcitabine	Patients 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.
toripalimab with P-GemOx	Oxaliplatin	Patients 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	Pegaspargase	Patients will receive induction chemotherapy with pegaspargase, gemcitabine, oxaliplatin, every 3 weeks for 4 cycles before radiation. Definitive intensity-modulated radiotherapy (IMRT) will be given.
P-GemOx	Oxaliplatin	Patients will receive induction chemotherapy with pegaspargase, gemcitabine, oxaliplatin, every 3 weeks for 4 cycles before radiation. Definitive intensity-modulated radiotherapy (IMRT) will be given.
P-GemOx	Gemcitabine	Patients will receive induction chemotherapy with pegaspargase, gemcitabine, oxaliplatin, every 3 weeks for 4 cycles before radiation. Definitive intensity-modulated radiotherapy (IMRT) will be given.

Primary Outcome Measures

Name	Time	Method
progression free survival (PFS)	3 years

Secondary Outcome Measures

Name	Time	Method
overall survival (OS)	3 years
event free survival (EFS)	3 years
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
recurrence-free survival (RFS)	3 years
disease-free survival (DFS)	3 years

Trial Locations

Locations (1)

Guangdong General Hospital; 🇨🇳 Guangzhou, Guangdong, China