Clinical trial NCT00618384: TACE and Sorafenib for Advanced Hepatocellular Carcinoma (HCC)
Official title: Phase II Study Evaluating Transarterial Chemoembolization (TACE) in Combination With Sorafenib for the Treatment of Advanced Hepatocellular Carcinoma (HCC)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Keywords: TACE
hepatocellular carcinoma
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2008-02-20
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: determination of time to progression (TTP)
timeFrame: every 30 days after administration
Secondary outcomes:
measure: adverse events
timeFrame: 3-week-periods
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen Innere Medizin I
state: BW
city: Ulm
country: Germany
facility: Medizinische Universitätsklinik Ulm Innere Medizin I
state: BW
city: Muenchen
country: Germany
facility: Klinikum der Universität Großhardern
state: BY
city: Frankfurt
country: Germany
facility: Klinikum der Johann-Goethe-Universität
state: HE
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf Zentrum für Innere Medizin
state: HH
city: Mainz
country: Germany
facility: Johannes-Gutenberg-Universität Medizinische Klinik
state: RP
Study officials:
affiliation: Department of Gastroenterology, Hepatology and Infectiology University Duesseldorf
name: A. Erhardt, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Erhardt A, Kolligs F, Dollinger M, Schott E, Wege H, Bitzer M, Gog C, Lammert F, Schuchmann M, Walter C, Blondin D, Ohmann C, Haussinger D. TACE plus sorafenib for the treatment of hepatocellular carcinoma: results of the multicenter, phase II SOCRATES trial. Cancer Chemother Pharmacol. 2014 Nov;74(5):947-54. doi: 10.1007/s00280-014-2568-8. Epub 2014 Aug 31.