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)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 207
- 试验地点
- 1
- 主要终点
- progression free survival (PFS)
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •hemophagocytic syndrome or aggressive NK cell leukemia;
- •involvement of central nervous system;
- •previously received treatment of chemotherapy, radiotherapy, immunotherapy or biotherapy for lymphoma；
研究组 & 干预措施
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.
干预措施: Toripalimab (Drug)
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.
干预措施: Pegaspargase (Drug)
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.
干预措施: Gemcitabine (Drug)
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.
干预措施: Oxaliplatin (Drug)
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.
干预措施: Definitive intensity-modulated radiotherapy (IMRT) (Radiation)
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.
干预措施: Pegaspargase (Drug)
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.
干预措施: Gemcitabine (Drug)
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.
干预措施: Oxaliplatin (Drug)
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.
干预措施: Definitive intensity-modulated radiotherapy (IMRT) (Radiation)
结局指标
主要结局
progression free survival (PFS)
时间窗: 3 years
次要结局
- 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)
研究者
Qingqing Cai
Chief physician
Sun Yat-sen University