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| Sponsor: | Kaohsiung Medical University Chung-Ho Memorial Hospital |
|---|---|
| Information provided by: | Kaohsiung Medical University Chung-Ho Memorial Hospital |
| ClinicalTrials.gov Identifier: | NCT00630240 |
Purpose
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.
| Condition |
|---|
|
Hepatocellular Carcinoma |
| Study Type: | Observational |
| Study Design: | Prospective |
| Official Title: | Investigation the Risk Factors for the Leakage of Anticancer Drugs to Systemic Circulation in Patients With Hepatocellular Carcinoma Treated by Transcatheter Arterial Chemoembolization |
plasma
| Enrollment: | 53 |
| Study Start Date: | February 2008 |
| Study Completion Date: | February 2009 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
1
only one arm for study
|
Eligibility| Ages Eligible for Study: | 20 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
hepatocellular carcinoma caused by hepatitis B or C
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Taiwan | |
| Division of Hepatobiliary Medicine, Department of Internal Medicine, Kaohsiung Medical University Hospital, No. 100 Tzyou 1st Road | |
| Kaohsiung, Taiwan, 807 | |
| Principal Investigator: | z y lin, MD, Ms | Kaohsiung Medical University |
More Information
| Responsible Party: | Kaoshing Medical University Chung-Ho Memorial Hospital ( Zu-Yau Lin/ Kaoshing Medical University Chung-Ho Memorial Hospital ) |
| Study ID Numbers: | KMUH-IRB-960297, KMUH-IRB-960297 |
| Study First Received: | February 26, 2008 |
| Last Updated: | August 30, 2009 |
| ClinicalTrials.gov Identifier: | NCT00630240 History of Changes |
| Health Authority: | Taiwan: Institutional Review Board |
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epirubicin mitomycin C cisplatin Hepatocellular carcinoma |
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Liver Neoplasms Liver Diseases Neoplasms Digestive System Diseases Neoplasms by Site Digestive System Neoplasms |
Neoplasms by Histologic Type Carcinoma, Hepatocellular Adenocarcinoma Neoplasms, Glandular and Epithelial Carcinoma |