Tislelizumab Plus Dose-Dense P-GemOx and Radiation Therapy for Early-Stage Intermediate/High-Risk Extranodal NK/T-Cell Lymphoma: A Multicenter Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Complete Response rate after 3 cycles of Anti-PD-1 antibody and P-GEMOX therapy
研究概览
简要总结
The current study is a phase II multi-center single arm trial to evaluate the efficacy and safety of inductive Anti-PD-1+P-GEMOX treatment followed by radiotherapy and concurrent Anti-PD-1 antibody in early-stage Intermediate/High-Risk extranodal NK/T cell lymphoma
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy proved extranodal NK/T cell lymphoma
- •No previous anti-cancer treatment
- •Measurable lesion on baseline PET/CT and MRI
- •Stage I-II
- •Have at lest one following risk factor: Elevated serum LDH level; PTI+; stage II
- •ECOG PS 0-1
- •Sufficient organ functions
排除标准
- •Other mature T- or NK- lymphoma
- •Hemophagocytic lymphohistiocytosis
- •Primary CNS lymphoma or CNS-involved lymphoma
- •History of malignancy except for cutaneous basal-/squamous- cell carcinoma or cervical carcinoma in situ 3 years prior to study treatment
研究组 & 干预措施
Inductive and concurrent anti-PD-1 antibody combined with chemo-radiotherapy
All the enrolled patients receive 3 cycles of anti-PD-1 antibody (Tislelizumab 200mg d1) + P-GEMOX (Pegaspargase 3000u d2, Gemcitabine 1g/m2 d2, Oxaliplatin 85mg/m2 d2) systemic treatment every 14 days, followed by involved-site radiotherapy with concurrent anti-PD-1 antibody (Tislelizumab 200mg) every two weeks.
干预措施: Pegaspargase (Drug)
Inductive and concurrent anti-PD-1 antibody combined with chemo-radiotherapy
All the enrolled patients receive 3 cycles of anti-PD-1 antibody (Tislelizumab 200mg d1) + P-GEMOX (Pegaspargase 3000u d2, Gemcitabine 1g/m2 d2, Oxaliplatin 85mg/m2 d2) systemic treatment every 14 days, followed by involved-site radiotherapy with concurrent anti-PD-1 antibody (Tislelizumab 200mg) every two weeks.
干预措施: Oxaliplatin (Drug)
Inductive and concurrent anti-PD-1 antibody combined with chemo-radiotherapy
All the enrolled patients receive 3 cycles of anti-PD-1 antibody (Tislelizumab 200mg d1) + P-GEMOX (Pegaspargase 3000u d2, Gemcitabine 1g/m2 d2, Oxaliplatin 85mg/m2 d2) systemic treatment every 14 days, followed by involved-site radiotherapy with concurrent anti-PD-1 antibody (Tislelizumab 200mg) every two weeks.
干预措施: Anti-PD-1 monoclonal antibody (Drug)
Inductive and concurrent anti-PD-1 antibody combined with chemo-radiotherapy
All the enrolled patients receive 3 cycles of anti-PD-1 antibody (Tislelizumab 200mg d1) + P-GEMOX (Pegaspargase 3000u d2, Gemcitabine 1g/m2 d2, Oxaliplatin 85mg/m2 d2) systemic treatment every 14 days, followed by involved-site radiotherapy with concurrent anti-PD-1 antibody (Tislelizumab 200mg) every two weeks.
干预措施: Involved site radiotherapy (Radiation)
Inductive and concurrent anti-PD-1 antibody combined with chemo-radiotherapy
All the enrolled patients receive 3 cycles of anti-PD-1 antibody (Tislelizumab 200mg d1) + P-GEMOX (Pegaspargase 3000u d2, Gemcitabine 1g/m2 d2, Oxaliplatin 85mg/m2 d2) systemic treatment every 14 days, followed by involved-site radiotherapy with concurrent anti-PD-1 antibody (Tislelizumab 200mg) every two weeks.
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Complete Response rate after 3 cycles of Anti-PD-1 antibody and P-GEMOX therapy
时间窗: At the end of Cycle 3 (each cycle is 14 days)
To evaluate the complete response (CR) rate after 3 cycles of Anti-PD-1 antibody and P-GEMOX therapy according to Lyric 2016 criteria
次要结局
- acute toxicity(From enrollment to 3 months after treatment)
- Progression-free survival rate at year 2 after enrollment, 2y-PFS(2 year)
- Overall Survival rate at year 2/5 after enrollment，2y-/5y-OS(2-year, 5-year)
- Quality of Life，QoL(baseline, 1/3/6/12/24 months after treatment)
研究者
Shunan Qi
Chief Physician of Radiation Oncology
Cancer Institute and Hospital, Chinese Academy of Medical Sciences