TACE and Sorafenib for Advanced Hepatocellular Carcinoma (HCC) - Full Text View

Sponsored by:	Heinrich-Heine University, Duesseldorf
Information provided by:	Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:	NCT00618384

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 II

Drug Information available for: Sorafenib Sorafenib tosylate Chlorotrianisene

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Study Evaluating Transarterial Chemoembolization (TACE) in Combination With Sorafenib for the Treatment of Advanced Hepatocellular Carcinoma (HCC)

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 ]

Estimated Enrollment:	72
Study Start Date:	January 2008
Estimated Study Completion Date:	July 2011
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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

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, BW
Universitätsklinikum Tübingen Innere Medizin I
Tübingen, BW, Germany, 72076
Medizinische Universitätsklinik Ulm Innere Medizin I
Ulm, BW, Germany, 89081
Germany, by
Klinikum der Universität Großhardern
Muenchen, by, Germany, 81377
Germany, HE
Klinikum der Johann-Goethe-Universität
Frankfurt, HE, Germany, 60590
Germany, HH
Universitätsklinikum Hamburg-Eppendorf Zentrum für Innere Medizin
Hamburg, HH, Germany, 20246
Germany, RP
Johannes-Gutenberg-Universität Medizinische Klinik
Mainz, RP, Germany, 55131
Germany, ST
Martin-Luther-Universität Halle-Wittenberg Universitätsklinik u. Poliklinik für Innere Medizin I
Halle, ST, Germany, 06120

Sponsors and Collaborators

Heinrich-Heine University, Duesseldorf

Investigators

Principal Investigator:

A. Erhardt, PD Dr.

Department of Gastroenterology, Hepatology and Infectiology University Duesseldorf

More Information

Responsible Party:	Heinrich-Heine University, Duesseldorf Department of Gastroenterology, Hepatology and Infectiology ( Heinrich-Heine University, represented by Principal investigator PD Dr. Erhardt )
Study ID Numbers:	SOCRATES-072
Study First Received:	February 8, 2008
Last Updated:	February 8, 2008
ClinicalTrials.gov Identifier:	NCT00618384
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Heinrich-Heine University, Duesseldorf:

TACE
hepatocellular carcinoma

Study placed in the following topic categories:

Liver Neoplasms
Liver Diseases
Digestive System Diseases
Digestive System Neoplasms
Carcinoma, Hepatocellular
Liver neoplasms

Gastrointestinal Neoplasms
Adenocarcinoma
Sorafenib
Hepatocellular carcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009