TACE and Sorafenib for Advanced Hepatocellular Carcinoma (HCC) (SOCRATES)

June 6, 2012 updated by: Heinrich-Heine University, Duesseldorf

Phase II Study Evaluating Transarterial Chemoembolization (TACE) in Combination With Sorafenib for the Treatment of Advanced Hepatocellular Carcinoma (HCC)

For patients with advanced HCC not suitable for resection or liver transplantation but without extrahepatic manifestations, local therapy with TACE is regarded as standard treatment. The present study is planned to evaluate the combination of TACE and sorafenib. A combination of TACE with a multitarget inhibitor like sorafenib may further improve the outcome of patients with HCC.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • BW
      • Tübingen, BW, Germany, 72076
        • Universitätsklinikum Tübingen Innere Medizin I
      • Ulm, BW, Germany, 89081
        • Medizinische Universitätsklinik Ulm Innere Medizin I
    • BY
      • Muenchen, BY, Germany, 81377
        • Klinikum der Universität Großhardern
    • HE
      • Frankfurt, HE, Germany, 60590
        • Klinikum der Johann-Goethe-Universität
    • HH
      • Hamburg, HH, Germany, 20246
        • Universitätsklinikum Hamburg-Eppendorf Zentrum für Innere Medizin
    • RP
      • Mainz, RP, Germany, 55131
        • Johannes-Gutenberg-Universität Medizinische Klinik

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • with histologically confirmed HCC not suitable for resection or liver transplantation
  • Patients with measurable disease according to RECIST
  • Performance status ECOG 0-2
  • Normal organ and bone marrow function (defined)
  • Women of childbearing potential must have performed a negative serum pregnancy test
  • male or female patients must use an approved contraceptive method during treatment and for 3 months after end of treatment after the end of treatment with study medication
  • Written informed consent

Exclusion Criteria:

  • Patient is eligible for liver resection or liver transplantation
  • Extrahepatic tumor manifestation
  • Thrombosis of the portal vein
  • > 8 points according to Child Pugh classification
  • Prior TACE or RFTA or any other local ablative treatment
  • Prior systemic anticancer chemotherapy or radiotherapy for HCC
  • Total bilirubin > 4.5 mg/dl
  • Life expectancy of less than 12 weeks
  • Esophageal varices grade III without prophylactic band ligation
  • Cardiac diseases (defined)
  • Uncontrolled hypertension
  • Known or suspected hyperthyroid state
  • Known brain metastasis
  • Patients with seizure disorder requiring medication
  • History of organ allograft
  • Active clinically serious infections > CTCAE grade 2
  • Thrombotic or embolic events
  • Hemorrhage/bleeding event (defined)
  • Acute variceal bleeding
  • Therapeutic anticoagulation with vitamin K antagonists (defined)
  • Known or suspected allergies to sorafenib, doxorubicin or lipiodol or any agent given in the course of this trial
  • Contraindications to the use of sorafenib, doxorubicin or lipiodol
  • Previous cancer distinct in primary site or histology from HCC (defined)
  • substance abuse
  • Participation in another clinical trial with any investigational study drug
  • Lactating women
  • Incapability to give valid informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Patients with TACE therapy will be treated with Sorafenib (2 x 400 mg/day) until progressive disease
Drug: Sorafenib
patients get transarterial chemoembolization (TACE) will get film-coated tablets of Sorafenib (2 x 400 mg/day) until progressive disease
Other Names:
  • Nexavar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
determination of time to progression (TTP)
Time Frame: every 30 days after administration
every 30 days after administration

Secondary Outcome Measures

Outcome Measure
Time Frame
adverse events
Time Frame: 3-week-periods
3-week-periods

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heinrich-Heine University, Duesseldorf

Investigators

  • Principal Investigator: A. Erhardt, PD Dr., Department of Gastroenterology, Hepatology and Infectiology University Duesseldorf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

February 8, 2008

First Submitted That Met QC Criteria

February 8, 2008

First Posted (Estimate)

February 20, 2008

Study Record Updates

Last Update Posted (Estimate)

June 7, 2012

Last Update Submitted That Met QC Criteria

June 6, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOCRATES-072

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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