Trans-catheter Arterial p53-gene-embolization Using Gelatin Sponge Particles in Treatment of Patients With Advanced Hepatocellular Carcinoma: A Phase II Study
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- overall survival
研究概览
简要总结
An open-labeled, randomized, active-controlled phase II study to investigate clinical efficacy and immunoreaction using trans-catheter arterial embolization (TAE) combined with p53 gene therapy in treatment of advanced hepatocellular carcinoma (HCC).
详细描述
Treatment options for advanced HCC are limited due to patients' poor condition, advanced stage, concomitant intra- and extra-liver diseases, and resistance to both chemo- and radio-therapy. Trans-catheter embolization (TAE) is a safe locoregional treatment for advanced HCC and p53 gene has multiple anticancer functions, and both methods do not have immune-inhibitory effects as chemo- or radio-therapy. The objectives of this study are to investigate clinical efficacy and immunoreaction usingTAE plus recombinant adenoviral human p53 gene (rAd-p53) in treatment of advanced HCC.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histopathologically diagnosed unresectable HCC
- •over 18 years old
- •with an Eastern Cooperative Oncology Group (ECOG) score of 0-2
- •with Barcelona Clinic Liver Cancer (BCLC) Stage of B or C
- •with Child-Pugh score A or B; with normal tests of hemogram, blood coagulation, liver and kidney function
- •signed the informed consent form.
排除标准
- •hypersensitive to study drug
- •With an abnormal coagulation condition or bleeding disorder
- •infections
- •with serious conditions which prevent using the study treatment
- •pregnant or lactating
研究组 & 干预措施
TAE plus p53 gene
Trans-catheter embolization (TAE) combined with recombinant adenoviral human p53 gene (rAd-p53) will be given one per month
干预措施: TAE plus P53 gene (Drug)
TAE
Trans-catheter embolization (TAE) will be given once per month
干预措施: TAE (Other)
结局指标
主要结局
overall survival
时间窗: 2 years
overall survival will be follow up to 2 years
次要结局
- immuno-reaction (lymphocyte counts and subgroup ratios)(3 months)
- progression free survival(2 years)