TACE and Sorafenib for Advanced Hepatocellular Carcinoma (HCC) (SOCRATES)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:
NCT00618384
First received: February 8, 2008
Last updated: June 6, 2012
Last verified: June 2012

February 8, 2008
June 6, 2012
January 2008
May 2011   (final data collection date for primary outcome measure)
determination of time to progression (TTP) [ Time Frame: every 30 days after administration ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00618384 on ClinicalTrials.gov Archive Site
adverse events [ Time Frame: 3-week-periods ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
TACE and Sorafenib for Advanced Hepatocellular Carcinoma (HCC)
Phase II Study Evaluating Transarterial Chemoembolization (TACE) in Combination With Sorafenib for the Treatment of Advanced Hepatocellular Carcinoma (HCC)

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatocellular Carcinoma
Drug: Sorafenib
patients get transarterial chemoembolization (TACE) will get film-coated tablets of Sorafenib (2 x 400 mg/day) until progressive disease
Other Name: Nexavar
Active Comparator: 1
Patients with TACE therapy will be treated with Sorafenib (2 x 400 mg/day) until progressive disease
Intervention: Drug: Sorafenib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
43
August 2011
May 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00618384
SOCRATES-072
No
Heinrich-Heine University, Duesseldorf
Heinrich-Heine University, Duesseldorf
Not Provided
Principal Investigator: A. Erhardt, PD Dr. Department of Gastroenterology, Hepatology and Infectiology University Duesseldorf
Heinrich-Heine University, Duesseldorf
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP