Liver Transplantation With ADV-TK Gene Therapy Improves Survival in Patients With Advanced Hepatocellular Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- overall survival rate at one year
研究概览
简要总结
Previous rather poor results in liver transplantation (LT) of patients with advanced hepatocellular carcinoma (HCC) have made the application of LT very limited in treatment of HCC. The advantages of ADV-TK gene therapy highlight its potentiality as adjuvant treatment for HCC patients after LT. We reported here the improved outcome of LT with combined treatment of ADV-TK gene therapy in patients with intermediate or advanced HCC.
详细描述
The overall survival in the LT with ADV-TK gene therapy group was 54.8 % at three years, and the recurrence-free survival in the same group was 56.5 %, both being higher than those in the transplantation only group (P=0.0001 for overall survival and P=0.0000 for recurrence-free survival). In no-vascular invasion subgroup treated with LT with ADV-TK therapy, both overall survival and recurrence-free survival were 100 %, significantly higher than those with vascular invasion subgroup treated with the combined LT and ADV-TK therapy (P=0 for each group). Vascular invasion was an important factor affected survival and recurrence, hazard ratio=3.687; P=0.014 and hazard ratio=12.961; P=0.000, respectively.
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
- 0 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of advanced hepatocellular carcinoma with no metastasis in lungs and bones
- •Accept Liver Transplantation
排除标准
- •Small hepatocellular carcinoma
- •Advanced hepatocellular with metastasis in lungs and bones
结局指标
主要结局
overall survival rate at one year
overall survival rate at two year
overall survival rate at three year
overall recurrence-free survival rate at one year
overall recurrence-free survival rate at two year
overall recurrence-free survival rate at three year
次要结局
- AFP level before and after liver transplantation
- hazard rate of age on survival rate and recurrence-free survival rate
- hazard rate of TNM stage on survival rate and recurrence-free survival rate
- hazard rate of Child-Pugh classification on survival rate and recurrence-free survival rate
- hazard rate of vascular invasion on survival rate and recurrence-free survival rate