Combination of Anti-PD-1 and NK Immunotherapy for Recurrent Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
The aim of this study is the safety and efficacy of anti-PD-1 plus NK immunotherapy to multiple solid tumors.
详细描述
By enrolling patients with solid tumors adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using anti-PD-1 and natural killer (NK) cells.
The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
- •Progression after chemotherapy or appropriate TKI treatment for those patients with an EGFR-sensitizing mutation or ALK rearrangement
- •KPS ≥ 70, lifespan > 3 months, PD-L1 TPS of 1% or greater
- •Platelet count ≥ 80×10^9/L，white blood cell count ≥ 3×10^9/L, neutrophil count ≥ 2×10^9/L, hemoglobin ≥ 80 g/L
排除标准
- •Patients with cardiac pacemaker
- •Patients with brain metastasis
- •Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction, myelosuppression, autoimmune disease, pneumonitis
- •Previous treatment with a therapeutic antibody against CTLA4, PD-L1, or PD-1, or PD-L1/PD-1 pathway-targeting agents.
研究组 & 干预措施
Pembrolizumab and NK immunotherapy
In this group, the patients will receive regular Pembrolizumab first to control tumor burden; then NK immunotherapy will be given. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
干预措施: Pembrolizumab (Drug)
Pembrolizumab and NK immunotherapy
In this group, the patients will receive regular Pembrolizumab first to control tumor burden; then NK immunotherapy will be given. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
干预措施: NK immunotherapy (Biological)
Pembrolizumab
In this group, the patients will receive regular Pembrolizumab to control tumor burden. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
干预措施: Pembrolizumab (Drug)
结局指标
主要结局
PFS
时间窗: 2 year
PFS was defined as the interval between treatment initiation and local relapse,
OS
时间窗: 3 years
OS was calculated as the interval from treatment initiation to death.
次要结局
- CTC(3 months)
- Tumor size(3 months)
- PD-1(3 months)
- CEA(3 months)