TACE and Sorafenib for Advanced Hepatocellular Carcinoma (HCC)

Hepatocellular Carcinoma Clinical Trial

— SOCRATES  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00618384
• Other study ID #: SOCRATES-072
• Status: Terminated
• Phase: Phase 2
• First received: February 8, 2008
• Last updated: June 6, 2012
• Start date: January 2008
• Est. completion date: August 2011

Study information

• Verified date: June 2012
• Source: Heinrich-Heine University, Duesseldorf
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 43
• Est. completion date: August 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Sorafenib
patients get transarterial chemoembolization (TACE) will get film-coated tablets of Sorafenib (2 x 400 mg/day) until progressive disease

Locations

Country	Name	City	State
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	Klinikum der Universität Großhardern	Muenchen	BY
Germany	Universitätsklinikum Tübingen Innere Medizin I	Tübingen	BW
Germany	Medizinische Universitätsklinik Ulm Innere Medizin I	Ulm	BW

Sponsors (1)

Lead Sponsor	Collaborator
Heinrich-Heine University, Duesseldorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	determination of time to progression (TTP)		every 30 days after administration	No
Secondary	adverse events		3-week-periods	Yes