A Controlled Clinic Trial to Survey the Outcome of Immunotherapy Using Precision T Cells Specific to Multiple Common Tumor-Associated Antigen in Treating Patients Underwent Radical Surgery for Hepatocellular Carcinoma
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Progress-free survival
研究概览
简要总结
Objectives:
The purpose of this study is to evaluate the safety and efficacy of radical surgery combined with dendritic cell-precision multiple antigen T cells in reducing the recurrence and metastasis of liver cancer
Methods:
This study designs a novel therapy using dendritic cell-precision multiple antigen T cells. 60 postoperative patients of hepatocellular carcinoma will be enrolled. They are randomly divided into postoperative routine therapy group and dendritic cell-precision multiple antigen T cells combined with postoperative routine therapy group. Dendritic cell-precision multiple antigen T cells treatments will be performed every 3 weeks with a total of three periods. The mail clinical indicators are Progression-Free-Survival and Overall Survival.
详细描述
A total of 60 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
- •Signed informed consent
- •Diagnosis of hepatocellular carcinoma (HCC), radical surgery was performed
- •The recurrence of HCC was not found after the Operation and no other immunotherapy was carried out
- •The Eastern Cooperative Oncology Group (ECOG) score ≤2
- •Child-Pugh score of liver function ≤ 9
- •Routine blood meets the requirements
排除标准
- •Expected Overall survival < 3 months
- •Radical surgery was not performed or recurrence was found after operation
- •Liver function is Childs Pugh C
- •Had received other immunotherapy
- •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
次要结局
- Overall survival(2 years)
- Quality of life(2 years)