Combination of Cryosurgery and NK Immunotherapy for Tumors in Transplanted Liver
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
研究概览
简要总结
The aim of this study is the safety and efficacy of cryosurgery plus natural killer(NK) immunotherapy to tumors in transplanted liver.
详细描述
By enrolling patients with tumors in transplanted liver 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 cryosurgery and 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
- 30 Years 至 60 Years（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
- •Body tumor 1-6, the maximum tumor length < 5 cm
- •KPS ≥ 70, lifespan > 6 months
- •Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/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
研究组 & 干预措施
Cryosurgery and NK immunotherapy
In this group, the patients will receive liver cryosurgery first to destroy big tumors, then receive multiple NK immunotherapy (intensive treatment: 6 times in first 3 months; then interval treatment: once every 3 months). The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
干预措施: Cryosurgery (Device)
Cryosurgery and NK immunotherapy
In this group, the patients will receive liver cryosurgery first to destroy big tumors, then receive multiple NK immunotherapy (intensive treatment: 6 times in first 3 months; then interval treatment: once every 3 months). 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)
Cryosurgery
In this group, the patients will receive liver cryosurgery to destroy big tumors. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
干预措施: Cryosurgery (Device)
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
时间窗: 3 months
次要结局
- Progress free survival（PFS）(1 year)
- Overall survival（OS）(3 years)