Status:
TERMINATED
TACE and Sorafenib for Advanced Hepatocellular Carcinoma (HCC)
Lead Sponsor:
Heinrich-Heine University, Duesseldorf
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00618384
Start Date
January 1 2008
End Date
August 1 2011
Last Update
June 7 2012
Active Locations (6)
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1
Universitätsklinikum Tübingen Innere Medizin I
Tübingen, Baden-Wurttemberg, Germany, 72076
2
Medizinische Universitätsklinik Ulm Innere Medizin I
Ulm, Baden-Wurttemberg, Germany, 89081
3
Klinikum der Universität Großhardern
Munich, Bavaria, Germany, 81377
4
Universitätsklinikum Hamburg-Eppendorf Zentrum für Innere Medizin
Hamburg, Hamburg, Germany, 20246