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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00618384
Recruitment Status : Terminated
First Posted : February 20, 2008
Last Update Posted : June 7, 2012
Information provided by (Responsible Party):
Heinrich-Heine University, Duesseldorf

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: Sorafenib Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study Evaluating Transarterial Chemoembolization (TACE) in Combination With Sorafenib for the Treatment of Advanced Hepatocellular Carcinoma (HCC)
Study Start Date : January 2008
Actual Primary Completion Date : May 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

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 Name: Nexavar

Primary Outcome Measures :
  1. determination of time to progression (TTP) [ Time Frame: every 30 days after administration ]

Secondary Outcome Measures :
  1. adverse events [ Time Frame: 3-week-periods ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00618384

Universitätsklinikum Tübingen Innere Medizin I
Tübingen, BW, Germany, 72076
Medizinische Universitätsklinik Ulm Innere Medizin I
Ulm, BW, Germany, 89081
Klinikum der Universität Großhardern
Muenchen, BY, Germany, 81377
Klinikum der Johann-Goethe-Universität
Frankfurt, HE, Germany, 60590
Universitätsklinikum Hamburg-Eppendorf Zentrum für Innere Medizin
Hamburg, HH, Germany, 20246
Johannes-Gutenberg-Universität Medizinische Klinik
Mainz, RP, Germany, 55131
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
Principal Investigator: A. Erhardt, PD Dr. Department of Gastroenterology, Hepatology and Infectiology University Duesseldorf

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Heinrich-Heine University, Duesseldorf Identifier: NCT00618384     History of Changes
Other Study ID Numbers: SOCRATES-072
First Posted: February 20, 2008    Key Record Dates
Last Update Posted: June 7, 2012
Last Verified: June 2012

Keywords provided by Heinrich-Heine University, Duesseldorf:
hepatocellular carcinoma

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs