Recurrence and Distant Metastases in Hepatocellular Carcinoma Treated by Transcatheter Arterial Chemoembolization

Completed

• Conditions: Hepatocellular Carcinoma

• Registration Number: NCT00834028
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Brief Summary

This project will include at least 40 patients with hepatocellular carcinoma (HCC) who will receive transcatheter arterial chemoembolization (TACE) as a sole method for the management. The serum is collected before and at the 3rd and 7th day after TACE. The serum levels of vascular endothelial growth factor, angiopoietin 2, endostatin and cathepsin L are determined. All patients will be evaluated according to the TNM system for the cancer staging before and 3 months after each session of treatment. The vascularity of tumor, the drug and the dose used for embolization, and the area of infarction will be recorded. These data will be compared with the clinical courses of the patients to obtain the most suitable way in the management of these patients.

Detailed Description

Transcatheter arterial chemoembolization (TACE) is the traditional method for the palliative management of patients with hepatocellular carcinoma (HCC). This method will cause tissue hypoxia in area of embolization. Several proangiogenic factors will be induced by the condition of hypoxia. This may have the possibility to promote the proliferation of the residual cancer cells. However, there is no study to clarify this issue. This project will determine the serial changes of serum proangiogenic factors (vascular endothelial growth factor, angiopoietin 2), antiangiogenic factor (endostatin) and cathepsin L before and after TACE. These data will be compared with the clinical courses of the patients to obtain the most suitable way in the management of these patients.

This project will include at least 40 patients with HCC who will receive TACE as a sole method for the management. The serum is collected before and at the 3rd and 7th day after TACE. The serum levels of vascular endothelial growth factor, angiopoietin 2, endostatin and cathepsin L are determined. All patients will be evaluated according to the TNM system for the cancer staging before and 3 months after each session of treatment. The vascularity of tumor, the drug and the dose used for embolization, and the area of infarction will be recorded.

Study Timeline

• Status Verified: 2006-11
• Study Start: 2007-02
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Study First Submitted: 2009-02-01
• Study First Submitted QC: 2009-02-01
• Last Update Submitted: 2009-02-01
• Study First Posted: 2009-02-03
• Last Update Posted: 2009-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• patients with hepatocellular carcinoma treated by transcatheter arterial chemoembolization

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Exclusion Criteria

• patients with hepatocellular carcinoma unable to be treated by transcatheter arterial chemoembolization

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
tumor progression	12 months

Trial Locations

Locations (1)

Kaohsiung Medical University Hospital; 🇨🇳 Kaohsiung, Taiwan