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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:
NCT00618384
First received: February 8, 2008
Last updated: June 6, 2012
Last verified: June 2012
History of Changes
  Purpose

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 Intervention Phase
Hepatocellular Carcinoma
 Drug: Sorafenib
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Heinrich-Heine University, Duesseldorf:

Primary Outcome Measures:
  • determination of time to progression (TTP) [ Time Frame: every 30 days after administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • adverse events [ Time Frame: 3-week-periods ] [ Designated as safety issue: Yes ]

Enrollment: 43
Study Start Date: January 2008
Study Completion Date: August 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00618384

Locations
Germany
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
Investigators
Principal Investigator: A. Erhardt, PD Dr. Department of Gastroenterology, Hepatology and Infectiology University Duesseldorf
  More Information

No publications provided

Responsible Party: Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT00618384     History of Changes
Other Study ID Numbers: SOCRATES-072
Study First Received: February 8, 2008
Last Updated: June 6, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Digestive System Diseases
Liver Diseases
Sorafenib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013