Skip to main content
OpenTrials
Completed

NCT Number: NCT01360255

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. comparison of liver cancer markers AFP, AFP-L3% and DCP before and after TACE

    Time frame: 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 outcomes

  1. comparison of quality of life before and after TACE

    Time frame: baseline and 3 months

    analysing the quality of life before and after TACE (3 months after TACE) using the EORTC- QLQ- C30.

  2. long-term survival (1-year, 3-year, 5-year)

    Time frame: up to 5 years

  3. progression- free - time

    Time frame: up to 5 years

Sponsors and collaborators

Lead sponsor

University Hospital Freiburg

Other

Collaborators

  • Wako Diagnostics

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
May 25, 2011
Registry last updated
Oct 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.