Clinical Research of in the Treatment of Unresectable Hepatocellular Carcinoma
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 400
- 主要终点
- OS of 1 years; TTP
研究概览
简要总结
Liver cancer is a highly invasive malignancy and the rate of surgical resection is no more than 28%. After diagnosis, the average survival rate of patient is less than 50% in 6 month, less than 24% in 1 year and 5% in 5 year. The TACE treatment, under the theoretical basis of blood supply of Liver cancer, is obviously better than the other non-surgical therapy, in terms of tumor regression, AFP decrease, survival time and the evaluation of the quality of life. However, its overall effect is not yet satisfactory. As a result, concerning the research of drug for liver cancer and improving the overall efficacy of the treatment of liver cancer has a very real and important clinical significance and social value. Licartin (Iodine-131-Labeled Metuximab) injection is a antibody drug with new target and the only drug that China own the intellectual property rights. It has specific high affinity with HAb18G/CD147, the liver cell membrane antigen. Labeled 131I is taken to the liver tissue, owning high-dose concentration and releasing β particles to liver cancer cells to and kill cancer cells.
The Second Military Medical University, Eastern Hepatobiliary Surgery Hospital, planed to use the treatment of Licartin combined with TACE for the patients of unresectable hepatocellular carcinoma and evaluate the difference of tumor size, AFP change, TTP, the overall survival rate between different treatment group.
详细描述
Liver cancer is a highly invasive malignancy and the rate of surgical resection is no more than 28%. The TACE treatment, under the theoretical basis of blood supply of Liver cancer, is obviously better than the other non-surgical therapy, in terms of tumor regression, AFP decrease, survival time and the evaluation of the quality of life. Licartin injection is a antibody drug with new target and the only drug that China own the intellectual property rights. It has specific high affinity with HAb18G/CD147, the liver cell membrane antigen. Labeled 131I is taken to the liver tissue, owning high-dose concentration and releasing β particles to liver cancer cells to and kill cancer cells.
The Second Military Medical University, Eastern Hepatobiliary Surgery Hospital, planed to use the treatment of Licartin combined with TACE for the patients of unresectable hepatocellular carcinoma and evaluate the difference of tumor size, AFP change, TTP, the overall survival rate between different treatment group.
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
- •the participation is entirely voluntary, good at compliance, sign the informed consent form in person;
- •diagnosed to be hepatocellular carcinoma by clinical method, imaging method and tumor markers; and the surgeons determine who can not undergo surgery;
- •confirmed to recurrent after surgery by pathology;
- •KPS score of physical state ≥ 60 points;
- •liver function is Child-Pugh A or B class
排除标准
- •General situation is poor and liver function Child-Pugh is C class;
- •there is a serious heart, kidney and blood system diseases in patients;
- •poor compliance;
- •there is allergy history of biological agents or in a state of allergy;
- •pregnancy and breast-feeding women
研究组 & 干预措施
control
干预措施: Transcatheter arterial chemoembolization (Procedure)
therapy
干预措施: Licartin (Drug)
therapy
干预措施: Transcatheter arterial chemoembolization (Procedure)
结局指标
主要结局
OS of 1 years; TTP
时间窗: 2008.12--2010-12
次要结局
未报告次要终点
研究者
ShenFeng
vice president of the Eastern Hepatobiliary Surgery Hospotal
Eastern Hepatobiliary Surgery Hospital