NCT00618384

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P50-P75 for phase_2 hepatocellular-carcinoma

Timeline
Completed

Started Jan 2008

Typical duration for phase_2 hepatocellular-carcinoma

Geographic Reach
1 country

6 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 8, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 20, 2008

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

June 7, 2012

Status Verified

June 1, 2012

Enrollment Period

3.3 years

First QC Date

February 8, 2008

Last Update Submit

June 6, 2012

Conditions

Hepatocellular Carcinoma

Keywords

TACEhepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

  • determination of time to progression (TTP)

    every 30 days after administration

Secondary Outcomes (1)

  • adverse events

    3-week-periods

Study Arms (1)

1

ACTIVE COMPARATOR

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

Drug: Sorafenib

Interventions

SorafenibDRUG

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

Also known as: Nexavar
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Universitätsklinikum Tübingen Innere Medizin I

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Medizinische Universitätsklinik Ulm Innere Medizin I

Ulm, Baden-Wurttemberg, 89081, Germany

Location

Klinikum der Universität Großhardern

Munich, Bavaria, 81377, Germany

Location

Universitätsklinikum Hamburg-Eppendorf Zentrum für Innere Medizin

Hamburg, Hamburg, 20246, Germany

Location

Klinikum der Johann-Goethe-Universität

Frankfurt am Main, Hesse, 60590, Germany

Location

Johannes-Gutenberg-Universität Medizinische Klinik

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Related Publications (1)

  • 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.

    PMID: 25173458DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Phenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • A. Erhardt, PD Dr.

    Department of Gastroenterology, Hepatology and Infectiology University Duesseldorf

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2008

First Posted

February 20, 2008

Study Start

January 1, 2008

Primary Completion

May 1, 2011

Study Completion

August 1, 2011

Last Updated

June 7, 2012

Record last verified: 2012-06

Locations

DE(6)