Trial Condition(s):

Carcinoma, Hepatocellular

A Phase II randomized, double-blind, placebo-controlled study of sorafenib or placebo in combination with transarterial chemoembolization (TACE) performed with DC Bead and doxorubicin for intermediate stage hepatocellular carcinoma (HCC).

Bayer Identifier:

12918

ClinicalTrials.gov Identifier:

NCT00855218

EudraCT Number:

2008-005056-24

Study Completed

Trial Purpose

This study will look at whether our drug (sorafenib) in combination with chemotherapy delivered directly into your tumor using beads (DC Bead) will slow the progression of the disease. The beads used with the chemotherapy will slowly release the chemotherapy reducing the adverse effects that normally occur with chemotherapy.

Inclusion Criteria
- Unresectable, multinodular asymptomatic tumor without vascular invasion or extrahepatic spread
 - Confirmed Diagnosis of HCC: 
 - Cirrhotic subjects: Clinical diagnosis by American Association for the Study of Liver Diseases (AASLD) criteria 
  - HCC can be defined in cirrhotic subjects by one imaging technique (Computed tomography [CT] scan, Magnetic resonance imaging [MRI], or second generation contrast ultrasound) showing a nodule larger than 2 cm with contrast uptake in the arterial phase and washout in venous or late phases or two imaging techniques showing this radiological behavior for nodules of 1-2 cm in diameter. 
  - Cytohistological confirmation is required for subjects who do not fulfill these eligibility criteria.
  - Non-cirrhotic subjects: 
For subjects without cirrhosis, histological or cytological confirmation is mandatory
 - Documentation of original biopsy for diagnosis is acceptable
 - Child Pugh class A without ascites
 - Adequate bone marrow, liver and renal function as assessed by central lab by means of the following laboratory requirements from samples within 7 days prior to randomization:
Exclusion Criteria
- Patients on a liver transplantation list or with advanced liver disease as defined below: 
  - Child Pugh B and C
  - Active gastrointestinal bleeding
  - Encephalopathy 
  -Ascites 
 - Lesions having previously been treated with local therapy such as resection of HCC, radiofrequency ablation (RFA), percutaneous ethanol injection (PEI) or cryoablation can not be selected as the target lesions.

Trial Summary

Enrollment Goal
307
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
Yes
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Freiburg, Germany, 79106

Status
Completed
 
Locations

Investigative Site

Tübingen, Germany, 72076

Status
Terminated
 
Locations

Investigative Site

Heidelberg, Germany, 69120

Status
Completed
 
Locations

Investigative Site

Hannover, Germany, 30625

Status
Terminated
 
Locations

Investigative Site

Jena, Germany, 07743

Status
Terminated
 
Locations

Investigative Site

Erlangen, Germany, 91054

Status
Completed
 
Locations

Investigative Site

Regensburg, Germany, 93042

Status
Completed
 
Locations

Investigative Site

Münster, Germany, 48149

Status
Completed
 
Locations

Investigative Site

Essen, Germany, 45136

Status
Completed
 
Locations

Investigative Site

New York, United States, 10029

Status
Completed
 
Locations

Investigative Site

Seattle, United States, 98109-1023

Status
Terminated
 
Locations

Investigative Site

St. Louis, United States, 63104

Status
Completed
 
Locations

Investigative Site

Portland, United States, 97239

Status
Completed
 
Locations

Investigative Site

Hamburg, Germany, 20246

Status
Completed
 
Locations

Investigative Site

Berlin, Germany, 13353

Status
Terminated
 
Locations

Investigative Site

Mainz, Germany, 55131

Status
Completed
 
Locations

Investigative Site

Essen, Germany, 45147

Status
Completed
 
Locations

Investigative Site

München, Germany, 81377

Status
Completed
 
Locations

Investigative Site

Frankfurt, Germany, 60590

Status
Completed
 
Locations

Investigative Site

Homburg, Germany, 66421

Status
Completed
 
Locations

Investigative Site

Ann Arbor, United States, 48109-0330

Status
Terminated
 
Locations

Investigative Site

La Jolla, United States, 92037

Status
Terminated
 
Locations

Investigative Site

Miami, United States, 33136

Status
Completed
 
Locations

Investigative Site

Detroit, United States, 48202

Status
Terminated
 
Locations

Investigative Site

Atlanta, United States, 30309-1231

Status
Completed
 
Locations

Abbott Northwestern Hospital

Minneapolis, United States, 55407

Status
Completed
 
Locations

Investigative Site

Orlando, United States, 32804

Status
Completed
 
Locations

Investigative Site

Los Angeles, United States, 90095-7077

Status
Terminated
 
Locations

Investigative Site

Columbus, United States, 43210-1240

Status
Completed
 
Locations

Investigative Site

Gainesville, United States, 32610-0316

Status
Completed
 
Locations

Investigative Site

Cleveland, United States, 44195

Status
Terminated
 
Locations

Investigative Site

Seattle, United States, 98101

Status
Completed
 
Locations

Investigative Site

San Francisco, United States, 94115

Status
Completed
 
Locations

Investigative Site

VILLEJUIF, France, 94805

Status
Completed
 
Locations

Investigative Site

PARIS, France, 75020

Status
Completed
 
Locations

Investigative Site

Marseille, France, 13005

Status
Completed
 
Locations

Investigative Site

CRETEIL, France, 94010

Status
Completed
 
Locations

Investigative Site

Pisa, Italy, 56124

Status
Completed
 
Locations

Investigative Site

Bologna, Italy, 40138

Status
Completed
 
Locations

Investigative Site

Roma, Italy, 00133

Status
Terminated
 
Locations

Investigative Site

Milano, Italy, 20133

Status
Completed
 
Locations

Investigative Site

Torino, Italy, 10126

Status
Completed
 
Locations

Investigative Site

Richmond, United States, 23249

Status
Completed
 
Locations

Investigative Site

LYON CEDEX, France, 69288

Status
Completed
 
Locations

Investigative Site

VANDOEUVRE-LES-NANCY, France, 54500

Status
Completed
 
Locations

Investigative Site

LILLE, France, 59037

Status
Completed
 
Locations

Investigative Site

PARIS, France, 75571

Status
Completed
 
Locations

Investigative Site

VILLEJUIF, France, 94800

Status
Completed
 
Locations

Investigative Site

Milano, Italy, 20122

Status
Completed
 
Locations

Investigative Site

Padova, Italy, 35128

Status
Completed
 
Locations

Investigative Site

Napoli, Italy, 80131

Status
Terminated
 
Locations

Investigative Site

Roma, Italy, 00185

Status
Completed
 
Locations

Investigative Site

Verona, Italy, 37134

Status
Completed
 
Locations

Investigative Site

Palermo, Italy, 90127

Status
Completed
 
Locations

Investigative Site

Bari, Italy, 70021

Status
Completed
 
Locations

Investigative Site

Badalona, Spain, 08916

Status
Completed
 
Locations

Investigative Site

Barcelona, Spain, 08035

Status
Completed
 
Locations

Investigative Site

Córdoba, Spain, 14004

Status
Completed
 
Locations

Investigative Site

A Coruña, Spain, 15006

Status
Terminated
 
Locations

Fundación Hospital Alcorcón

Alcorcón, Spain, 28922

Status
Completed
 
Locations

Hospital Central de Asturias

Oviedo, Spain, 33006

Status
Completed
 
Locations

Investigative Site

Sabadell, Spain, 08208

Status
Completed
 
Locations

Investigative Site

Madrid, Spain, 28034

Status
Completed
 
Locations

Investigative Site

Toronto, Canada, M5G 2N2

Status
Completed
 
Locations

Investigative Site

Calgary, Canada, T2N 4N1

Status
Completed
 
Locations

Investigative Site

Halifax, Canada, B3H 2Y9

Status
Completed
 
Locations

Investigative Site

LIEGE, Belgium, 4000

Status
Completed
 
Locations

Investigative Site

LEUVEN, Belgium, 3000

Status
Completed
 
Locations

Investigative Site

Heidelberg, Australia, 3084

Status
Completed
 
Locations

Investigative Site

Greenslopes, Australia, 4120

Status
Completed
 
Locations

Investigative Site

Wien, Austria, 1090

Status
Completed
 
Locations

Investigative Site

Guangzhou, China, 510060

Status
Completed
 
Locations

Investigative Site

Beijing, China, 100142

Status
Completed
 
Locations

Investigative Site

Shanghai, China, 200438

Status
Completed
 
Locations

Investigative Site

Shanghai, China, 200032

Status
Completed
 
Locations

Investigative Site

Guangzhou, China, 510080

Status
Terminated
 
Locations

Investigative Site

Xi'an, China, 710032

Status
Completed
 
Locations

Investigative Site

Seoul, South Korea, 120-752

Status
Completed
 
Locations

Investigative Site

Seoul, South Korea, 110-744

Status
Completed
 
Locations

Investigative Site

Gyeonggi-do, South Korea, 411-706

Status
Terminated
 
Locations

Investigative Site

Daegu, South Korea, 700-721

Status
Completed
 
Locations

Changhua Christian Hospital

Changhua, Taiwan, China, 500

Status
Completed
 
Locations

Investigative Site

Taipei, Taiwan, China, 10002

Status
Completed
 
Locations

Investigative Site

Taipei, Taiwan, China, 11217

Status
Completed
 
Locations

Investigative Site

Singapore, Singapore, 169610

Status
Completed
 
Locations

Investigative Site

Barcelona, Spain, 08036

Status
Completed
 
Locations

Investigative Site

Cruces/Barakaldo, Spain, 48903

Status
Completed
 
Locations

Investigative Site

La Laguna, Spain, 38320

Status
Completed
 
Locations

Hospital Universitario Virgen del Rocío

Sevilla, Spain, 41013

Status
Completed
 
Locations

Investigative Site

Madrid, Spain, 28046

Status
Completed
 
Locations

Investigative Site

Alicante, Spain, 03010

Status
Completed
 
Locations

Investigative Site

Valencia, Spain, 46014

Status
Completed
 
Locations

Investigative Site

Santiago de Compostela, Spain, 15706

Status
Completed
 
Locations

Investigative Site

BRUXELLES - BRUSSEL, Belgium, 1200

Status
Completed
 
Locations

Investigative Site

BRUXELLES - BRUSSEL, Belgium, 1070

Status
Completed
 
Locations

Investigative Site

BRUXELLES - BRUSSEL, Belgium, 1090

Status
Terminated
 
Locations

Investigative Site

St Leonards, Australia, 2065

Status
Terminated
 
Locations

Investigative Site

Camperdown, Australia, 2050

Status
Completed
 
Locations

Investigative Site

Nedlands, Australia, 6009

Status
Completed
 
Locations

Investigative Site

Melbourne, Australia, 3004

Status
Completed
 
Locations

Investigative Site

Clayton, Australia, 3168

Status
Completed
 
Locations

Investigative Site

Innsbruck, Austria, 6020

Status
Completed
 
Locations

Investigative Site

beijing, China, 100021

Status
Completed
 
Locations

Investigative Site

Seoul, South Korea, 135-710

Status
Completed
 
Locations

Gangnam Severance Hospital, Yonsei University

Seoul, South Korea, 135-720

Status
Terminated
 
Locations

Investigative Site

Singapore, Singapore, 119228

Status
Terminated
 
Locations

Investigative Site

Lyon, France, 69003

Status
Completed
 

Trial Design