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

Completed

• Conditions: Hepatocellular Carcinoma

• Registration Number: NCT01360255
• Lead Sponsor: University Hospital Freiburg

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2011-05-09
• Study First Submitted QC: 2011-05-24
• Study First Posted: 2011-05-25
• Status Verified: 2011-12
• Primary Completion: 2015-11
• Study Completion: 2015-11-15
• Last Update Submitted: 2018-10-10
• Last Update Posted: 2018-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
comparison of liver cancer markers AFP, AFP-L3% and DCP before and after TACE	baseline, 1 month and 3 months	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

Secondary Outcome Measures

Name	Time	Method
progression- free - time	up to 5 years
comparison of quality of life before and after TACE	baseline and 3 months	analysing the quality of life before and after TACE (3 months after TACE) using the EORTC- QLQ- C30.
long-term survival (1-year, 3-year, 5-year)	up to 5 years

Trial Locations

Locations (1)

University Medical Center Freiburg; 🇩🇪 Freiburg, Baden-Württemberg, Germany