TACE and Sorafenib for Advanced Hepatocellular Carcinoma (HCC)

Phase 2

Terminated

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Sorafenib

• Registration Number: NCT00618384
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-02-08
• Study First Submitted QC: 2008-02-08
• Study First Posted: 2008-02-20
• Primary Completion: 2011-05
• Study Completion: 2011-08
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-06
• Last Update Posted: 2012-06-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 43

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
determination of time to progression (TTP)	every 30 days after administration

Secondary Outcome Measures

Name	Time	Method
adverse events	3-week-periods

Trial Locations

Locations (6)

Universitätsklinikum Tübingen Innere Medizin I; 🇩🇪 Tübingen, BW, Germany

Medizinische Universitätsklinik Ulm Innere Medizin I; 🇩🇪 Ulm, BW, Germany

Klinikum der Universität Großhardern; 🇩🇪 Muenchen, BY, Germany

Klinikum der Johann-Goethe-Universität; 🇩🇪 Frankfurt, HE, Germany

Universitätsklinikum Hamburg-Eppendorf Zentrum für Innere Medizin; 🇩🇪 Hamburg, HH, Germany

Johannes-Gutenberg-Universität Medizinische Klinik; 🇩🇪 Mainz, RP, Germany