Sintilimab With P-GemOx (Pegaspargase, Gemcitabine and Oxaliplatin) Regimen for Newly Diagnosed Advanced Extranodal Natural Killer/T-cell Lymphoma, Nasal Type (ENKTL): a Single Arm, Open, Multicenter, Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- overall response rate (ORR)
研究概览
简要总结
The purpose of this multi-center,single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of Sintilimab with P-GemOx (pegaspargase, gemcitabine and oxaliplatin) regimen for newly diagnosed advanced extranodal natural killer/T-cell lymphoma, nasal type (ENKTL)
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 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 III/IV 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
Sintilimab With P-GemOx
Sintilimab, 200mg, d1, intravenous drip; pegaspargase, 2000U/m2, d1, intravenous drip; gemcitabine, 1000mg/m2, d1,d8, intravenous drip; oxaliplatin, 130mg/m2, d1, intravenous drip; All patients received up to 6 treatment cycles of 21 days. Patients with CR or PR will receive Sintilimab maintenance therapy.
干预措施: sintilimab,pegaspargase,gemcitabine,oxaliplatin (Drug)
结局指标
主要结局
overall response rate (ORR)
时间窗: 2years
complete remission (CR) rate
时间窗: 2years
次要结局
- overall survival (OS)(2years)
- progression survival (PFS)(2years)
- disease-free survival (DFS)(2years)
- bio-marker analysis(2years)
研究者
Qingqing Cai
Chief physician
Sun Yat-sen University