A Phase II Study to Investigate Preliminary Efficacy Using p53 Gene Therapy for Treatment of Diabetes Concurrent With Hepatocellular Carcinoma
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- fasting plasma glucose (FPG)
研究概览
简要总结
An open-labeled phase II study to investigate preliminary efficacy using p53 gene therapy in treatment of diabetes concurrent with hepatocellular carcinoma (HCC).
详细描述
It was found in the treatment of HCC using p53 gene therapy that the concurrent diabetes was controlled as well. The objectives of this study are to investigate both anti-diabetic and anti-tumor role of p53 gene therapy. This is an open-labeled, randomized, active-controlled phase 2 study. p53 will be injected via the artery, which supplies blood for the tumor nodules. The study endpoints for anti-diabetic role are fasting plasma glucose (FPG), postprandial glucose (PPG) and glycosylated hemoglobin (A1C) at 30 days after the start of treatment; and for antitumor effect are progression-free survival and overall survival.
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 therapy
Trans-catheter embolization (TAE) combined with recombinant adenoviral human p53 gene (rAd-p53) will be given one per month
干预措施: p53 gene therapy (Drug)
TAE plus p53 gene therapy
Trans-catheter embolization (TAE) combined with recombinant adenoviral human p53 gene (rAd-p53) will be given one per month
干预措施: Trans-catheter embolization (Drug)
Trans-catheter embolization
Trans-catheter embolization (TAE) will be given once per month
干预措施: Trans-catheter embolization (Drug)
结局指标
主要结局
fasting plasma glucose (FPG)
时间窗: from starting treatment until 60 days
In 60 days after starting study treatment
glycosylated hemoglobin (A1C)
时间窗: from starting treatment until 60 days
In 60 days after starting study treatment
次要结局
- overall survival (OS)(2 years)
- progression free survival (PFS)(2 years)
- postprandial glucose (PPG)(from starting treatment until 60 days)