Clinical Study on the Safety and Efficacy of Mixed-activated Killer Immune Cells in the Treatment of Primary Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- The size (tumor diameter) and number (tumor recurrence lesions) of PHC tumors were examined by enhanced abdominal CT
研究概览
简要总结
The investigators will plan to recruit 20 patients with liver cancer CNLC stage Ⅲa and Ⅲb who are older than 18 years old. Peripheral blood mononuclear cells were obtained and then the MAK(Mixed-activated Killer) cells were injected, and then the safety and efficacy were observed.
详细描述
The investigators will plan to recruit 20 patients with liver cancer CNLC stage Ⅲa and Ⅲb who are older than 18 years old. Peripheral venous blood was collected twice (50-60ml/time, 2 times, 1 week apart) from each patient. Peripheral blood mononuclear cells were separated, induced, expanded, and cultured in vitro for a total of 1 week to obtain physiological conditions Immune cell populations with tumor-killing activity (mainly MAK immune cells mainly CD3-CD16 + CD56 + and CD3 + CD56 +), and then the MAK(Mixed-activated Killer) cells were injected intravenously for three days. Observe that the patient received cell therapy 24h, The safety and efficacy of 1 month, 2 months, and 3 months, and monitoring of adverse reactions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years old, regardless of gender.
- •Patients with primary hepatocellular carcinoma.
- •According to the "Regulations for Diagnosis and Treatment of Primary Liver Cancer (2019 Edition)" by the Health Commission of the People's Republic of China Liver cancer staging scheme, patients with Ⅲa and Ⅲb.
- •The expected survival time is ≥6 months.
- •Peripheral blood white blood cell count ≥3×10^9 /L.
- •Understand and voluntarily sign the informed consent form.
排除标准
- •Patients with immunodeficiency or autoimmune diseases (such as rheumatoid arthritis, systemic lupus erythematosus, multiple Primary sclerosis, insulin dependent diabetes, etc.).
- •Patients with a history of other malignant tumors in the past 5 years.
- •Patients who participated in other clinical trials or clinical research treatments within 3 months before this clinical study By.
- •Patients who have received other cell therapy within the past 6 months.
- •Patients with fever who have not effectively controlled the infection.
- •Patients with high allergies or a history of severe allergies.
- •Patients who are allergic to albumin.
- •Patients after organ transplantation; patients who have been using or are using immunosuppressive agents for a long time.
结局指标
主要结局
The size (tumor diameter) and number (tumor recurrence lesions) of PHC tumors were examined by enhanced abdominal CT
时间窗: three months
At baseline and 1, 2 and 3 months after the last cell transfusion, a total of 4 abdominal enhanced CT examinations were performed to count the tumor size (tumor diameter) and number of tumor recurrence lesions.
Detecting the dynamic changes of circulating tumor cell count ( > 4 CTC counts per milliliter of blood acted as positive )
时间窗: three months
Peripheral blood was collected 6 times at baseline, 24 hours after two MAK cell transfusions, and 1, 2, and 3 months after the last MAK cell transfusions to detect the changes in the number of circulating tumor cells ( \> 4 CTC counts per milliliter of blood acted as positive ).
次要结局
未报告次要终点