AFP- L3% and DCP as Tumor Markers in Patients With Hepatocellular Carcinoma (HCC) Treated With Transarterial Chemoembolisation (TACE)

Hepatocellular Carcinoma Clinical Trial

Official title:

AFP - L3% and DCP as Tumor Markers in Patients With Hepatocellular Carcinoma (HCC) Treated With Transarterial Chemoembolisation (TACE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01360255
• Other study ID #: HCC2
• Secondary ID: DRKS00000812
• Status: Completed
• Start date: May 2010
• Est. completion date: November 15, 2015

Study information

• Verified date: December 2011
• Source: University Hospital Freiburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Hepatocellular carcinoma (HCC) is one of the tumors with an increasing incidence worldwide. Often treatment possibilities are limited and only palliative treatment such as a transarterial chemoembolisation (TACE) is possible. Therapeutic response is evaluated three months after TACE by imaging techniques (CT, MRI). In some HCC patients the tumor marker AFP ( alpha-fetoprotein) is elevated, but not all patients show this elevation. In the last years new tumor markers such as AFP-L3 (subfraction of AFP) and des-y-carboxyprothrombin (DCP) have been examined. In this clinical trial the course of these markers are examined after TACE in order to receive hints if the patient will be a therapeutic responder.

Furthermore the investigators are interested in the quality of life after TACE. Patients receive a questionnaire with regard to the quality of life before and 3 months after TACE.

Description:

Patients with hepatocellular carcinoma (HCC) treated with transarterial chemoembolisation are enrolled in this clinical trial. The aim of this trial is to evaluate the usefulness of the liver cancer markers AFP, AFP-L3% (subfraction of AFP) and des-y- carboxyprothrombin (DCP) after TACE therapy. Some authors could have shown that AFP-L3% is rising in small tumor nodules under 2 cm and so the markers which should decrease after TACE can give a hint for the therapeutic response after the intervention. So the important aim of this trial is to improve the early detection of tumor recurrence after TACE.

Furthermore the quality of life measured by the EORTC QLQ C30 before and after TACE is evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 15, 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• age between 18 and 80

• diagnosis of HCC according the AASLD criteria

• TACE is planned

• resection is impossible

Exclusion Criteria:

• liver tumor of unknown origin

• other liver tumors

• TACE is impossible

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Locations

Country	Name	City	State
Germany	University Medical Center Freiburg	Freiburg	Baden-Württemberg

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Freiburg	Wako Diagnostics

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	comparison of liver cancer markers AFP, AFP-L3% and DCP before and after TACE	Liver cancer markers AFP, AFP-L3 and DCP are measured before TACE, 1 month and 3 months after TACE in order to evaluate the course of these markers after the intervention	baseline, 1 month and 3 months
Secondary	comparison of quality of life before and after TACE	analysing the quality of life before and after TACE (3 months after TACE) using the EORTC- QLQ- C30.	baseline and 3 months
Secondary	long-term survival (1-year, 3-year, 5-year)		up to 5 years
Secondary	progression- free - time		up to 5 years