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

Tracking Information

First Received Date ^ICMJE

February 8, 2008

Last Updated Date

June 6, 2012

Start Date ^ICMJE

January 2008

Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00618384 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

TACE and Sorafenib for Advanced Hepatocellular Carcinoma (HCC)

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Hepatocellular Carcinoma

Intervention ^ICMJE

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

Study Arm (s)

Active Comparator: 1

Patients with TACE therapy will be treated with Sorafenib (2 x 400 mg/day) until progressive disease

Intervention: Drug: Sorafenib

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

August 2011

Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00618384

Other Study ID Numbers ^ICMJE

SOCRATES-072

Has Data Monitoring Committee

Responsible Party

Heinrich-Heine University, Duesseldorf

Study Sponsor ^ICMJE

Heinrich-Heine University, Duesseldorf

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

A. Erhardt, PD Dr.

Department of Gastroenterology, Hepatology and Infectiology University Duesseldorf

Information Provided By

Heinrich-Heine University, Duesseldorf

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top