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临床试验/NCT00630240
NCT00630240已完成不适用

Investigation the Risk Factors for the Leakage of Anticancer Drugs to Systemic Circulation in Patients With Hepatocellular Carcinoma Treated by Transcatheter Arterial Chemoembolization

Kaohsiung Medical University Chung-Ho Memorial Hospital1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2008年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
53
试验地点
1
主要终点
The blood levels of anticancer drugs (epirubicin, mitomycin C and cisplatin) will be determined within one hour and at the third day after TACE.

研究概览

简要总结

Hepatocellular carcinoma (HCC) is the most common malignant tumor of the liver. Transcatheter arterial chemoembolization (TACE) is the traditional method for the palliative management of patients with HCC. Few previous studies had demonstrated that the serum level of anticancer drug from patients treated by TACE was similar to those treated by systemic chemotherapy. The defense ability of the patient treated by TACE may thus be influenced by the leakage of anticancer drug to the systemic circulation. Since more than 80% patients with HCC also have liver cirrhosis, the toxicity for those anticancer drugs with hepatic transformation will be increased caused by the cirrhotic liver. The severity of pancytopenia in cirrhosis will be exacerbated by the effect of bone marrow suppression caused by anticancer drugs. Patients are at high risk for infection and hemorrhage. Therefore, it is of clinical importance to prevent or decrease the leakage of anticancer drugs to systemic circulation in patients treated by TACE. The procedures of TACE performed by previous studies were not constant and the distributions of tumor vessels were not evaluated in detail. The possible risk factors for the leakage of anticancer drug have not been investigated. This project will collect 60 patients with HCC including 30 patients with hepatitis B and 30 patients with hepatitis C. The blood levels of anticancer drugs (epirubicin, mitomycin C and cisplatin) will be determined within one hour and at the third day after TACE.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with hepatocellular carcinoma caused by hepatitis B or C who will be treated by TACE

排除标准

  • Previously treated by antiviral drugs for hepatitis B or C

结局指标

主要结局

The blood levels of anticancer drugs (epirubicin, mitomycin C and cisplatin) will be determined within one hour and at the third day after TACE.

时间窗: within one hour and at the third day after TACE

次要结局

未报告次要终点

研究者

研究点 (1)

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