NCT02862613Unknown1 期
Clinical Study Using Precision Cell Immunotherapy Combined With Transcatheter Arterial Chemoembolization in Advanced Liver Cancer
Shanghai International Medical Center1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年8月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Progress-free survival
研究概览
简要总结
Objectives:
To evaluate the safety and effectiveness of cell therapy using Precision Cells Combined With TACE in Advanced Liver Cancer.
Eligibility:
Individuals greater than or equal to 18 years of age and less than or equal to 65 years of age who have been diagnosed with Advanced Liver Cancer.
详细描述
A total of 40 patients may be enrolled over a period of 1-2 years.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18~65 years old, male or female;
- •Life expectancy≥6 months;
- •ECOG score: 0-3;
- •Advanced Malignancies (lung cancer, gastric cancer) were diagnosed by pathological or clinical physicians,and Diagnosis of hepatocellular carcinoma (HCC), surgery can not be performed but TACE treatment can be carried out;
- •Enough venous channel, no other contraindications to the separation and collection of white blood cells;
- •Laboratory examination: white blood cell≥3 x 10*9/L, blood platelet count≥60 x 10*/L, hemoglobin≥85g/L; lymphocyte count≥15%, total bilirubin≤100 mol/L; ALT and AST less than five times of the normal level; serum creatinine less than 1.5 times of the normal level;
- •Signed informed consent;
- •Women of child-bearing age must have evidence of negative pregnancy test and be willing to practice birth control after 2 weeks following the cells transfusion.
排除标准
- •Expected Overall survival < 3 months;
- •The tumor size or quantity is not suitable for interventional treatment or portal vein tumor thrombus;
- •Liver function is Childs Pugh C;
- •Had received TACE therapy previously or in radiotherapy at present,or taking Sola Feeney;
- •Other serious diseases:the heart,lung, kidney, digestive, nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc;
- •Unable or unwilling to provide informed consent, or fail to comply with the test requirements.
结局指标
主要结局
Progress-free survival
时间窗: 2 years
Overall survival
时间窗: 2 years
次要结局
- Quality of life(2 years)
研究者
研究点 (1)
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