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)
Overview
- Phase
- Phase 3
- Intervention
- Toripalimab
- Conditions
- NK/T Cell Lymphoma Nos
- Sponsor
- Sun Yat-sen University
- Enrollment
- 207
- Locations
- 1
- Primary Endpoint
- progression free survival (PFS)
- Status
- Recruiting
- Last Updated
- last year
Overview
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)
Investigators
Qingqing Cai
Chief physician
Sun Yat-sen University
Eligibility 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；
Arms & Interventions
toripalimab with P-GemOx
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.
Intervention: Toripalimab
toripalimab with P-GemOx
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.
Intervention: Pegaspargase
toripalimab with P-GemOx
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.
Intervention: Gemcitabine
toripalimab with P-GemOx
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.
Intervention: Oxaliplatin
toripalimab with P-GemOx
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.
Intervention: Definitive intensity-modulated radiotherapy (IMRT)
P-GemOx
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.
Intervention: Pegaspargase
P-GemOx
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.
Intervention: Gemcitabine
P-GemOx
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.
Intervention: Oxaliplatin
P-GemOx
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.
Intervention: Definitive intensity-modulated radiotherapy (IMRT)
Outcomes
Primary Outcomes
progression free survival (PFS)
Time Frame: 3 years
Secondary Outcomes
- 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)