Clinical trial NCT00834028: Recurrence and Distant Metastases in Hepatocellular Carcinoma Treated by Transcatheter Arterial Chemoembolization
Official title: Recurrence and Distant Metastases in Hepatocellular Carcinoma Treated by Transcatheter Arterial Chemoembolization : The Roles of VEGF, Cathepsin L, Endostatin, and Angiopoietin-2.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Keywords: hepatocellular carcinoma
vascular endothelial growth factor
angiopoietin
cathepsin
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2009-02-03
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with hepatocellular carcinoma

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.

Eligibility criteria: Inclusion Criteria:

* patients with hepatocellular carcinoma treated by transcatheter arterial chemoembolization

Exclusion Criteria:

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

Primary outcomes:
measure: tumor progression
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Hospital
Study officials:
affiliation: Kaohsiung Medical University
name: zu y lin
role: PRINCIPAL_INVESTIGATOR
References: