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Sponsored by: |
University of Bern |
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Information provided by: | University of Bern |
ClinicalTrials.gov Identifier: | NCT00478374 |
The purpose of this study is to determine the feasibility to combine sorafenib with transarterial chemoembolisation in patients suffering from hepatocellular carcinoma.The hypothesis is that sorafenib may prevent the development and growth of tumoral lesions not treated by chemoembolisation.
Condition | Intervention | Phase |
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Hepatocellular Carcinoma |
Drug: Sorafenib Procedure: Transarterial chemoembolisation with doxorubicin |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | Transarterial Chemoembolisation With Doxorubicin in Combination With Systemic Administration of Sorafenib for Patients With Hepatocellular Carcinoma |
Estimated Enrollment: | 21 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Sorafenib
Sorafenib 400mg bid
Procedure: Transarterial chemoembolisation with doxorubicin
Transarterial chemoembolisation (TACE)
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Normal organ and marrow function defined as:
Exclusion Criteria:
Active heart disease is defined as congestive heart failure >NYHA (New York Heart Association) class 2; active coronary artery disease (myocardial infarction more than 6 months prior to study entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy (beta-blockers or digoxin are permitted) or uncontrolled hypertension.
Contact: Jean-François J Dufour, MD | 0041316323191 | jf.dufour@ikp.unibe.ch |
Contact: Bettina Saar, MD | 0041316322111 | bettina.saar@insel.ch |
Switzerland | |
Inselspital | Recruiting |
Bern, Switzerland, 3010 | |
Principal Investigator: Jean-François J Dufour, MD |
Principal Investigator: | Daniel Candinas | Inselspital |
Principal Investigator: | Markus Borner | Inselspital |
Study Director: | Jean-François J Dufour, MD | Inselspital |
Responsible Party: | University of Bern ( J-F DUFOUR ) |
Study ID Numbers: | JFD-12581 |
Study First Received: | May 23, 2007 |
Last Updated: | June 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00478374 History of Changes |
Health Authority: | Switzerland: Swissmedic |
Liver Diseases Digestive System Neoplasms Carcinoma, Hepatocellular Protein Kinase Inhibitors Doxorubicin Carcinoma Liver Neoplasms |
Anti-Bacterial Agents Digestive System Diseases Gastrointestinal Neoplasms Adenocarcinoma Hepatocellular Carcinoma Sorafenib Neoplasms, Glandular and Epithelial |
Liver Diseases Neoplasms by Histologic Type Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Carcinoma, Hepatocellular Enzyme Inhibitors Antibiotics, Antineoplastic Protein Kinase Inhibitors Pharmacologic Actions |
Doxorubicin Carcinoma Liver Neoplasms Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Adenocarcinoma Sorafenib Neoplasms, Glandular and Epithelial |