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Sponsors and Collaborators: |
Institut Gustave Roussy Hoffmann-La Roche |
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Information provided by: | Institut Gustave Roussy |
ClinicalTrials.gov Identifier: | NCT00162669 |
Primary liver cancer (hepatocellular carcinoma) is the fifth most common malignant disorder, with an increasing incidence in Europe and the USA as a result of the high prevalence of hepatitis C. Most patients are not suitable for potentially curative treatment. There is no standard palliative treatment for patients with advanced hepatocellular carcinoma (HCC), as no drug has been demonstrated to be efficient in this disease in terms of survival. The use of anti-vascular agents might be a promising approach in view of the highly vascular nature of this tumor. The aim of this phase II trial is to evaluate the potential benefit of bevacizumab in terms of disease control rate, progression-free and overall survival in adult patients with advanced primary liver cancer.
Bevacizumab is an angiogenesis inhibitor already successfully used in patients with colorectal and renal cancers.
Condition | Intervention | Phase |
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Hepatocellular Carcinoma |
Drug: bevacizumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Phase II Study Evaluating the Efficacy of Bevacizumab (Avastin@) in Hepatocellular Carcinoma Not Amenable to Curative Treatment |
Estimated Enrollment: | 50 |
Study Start Date: | May 2005 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Valerie Boige, MD | 00 33 014-211-4308 | boige@igr.fr |
Contact: Jean-Pierre Pignon, MD, PhD | 00 33 014-211-4565 | jppignon@igr.fr |
France | |
Institut Gustave Roussy | Recruiting |
Villejuif, France, 94800 | |
Contact: Valérie BOIGE, Dr 00 33 014 211 43 08 boige@igr.fr |
Principal Investigator: | Valérie BOIGE, Dr | Institut Gustave Roussy |
Study ID Numbers: | IGR 1123, HCC-Avastin |
Study First Received: | September 8, 2005 |
Last Updated: | September 7, 2006 |
ClinicalTrials.gov Identifier: | NCT00162669 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Hepatocellular carcinoma, advanced, bevacizumab, phase II, VGEF, neovascularization |
Liver Diseases Digestive System Neoplasms Carcinoma, Hepatocellular Bevacizumab Angiogenesis Inhibitors Carcinoma Liver Neoplasms |
Digestive System Diseases Gastrointestinal Neoplasms Neovascularization, Pathologic Adenocarcinoma Hepatocellular Carcinoma Neoplasms, Glandular and Epithelial |
Liver Diseases Neoplasms by Histologic Type Digestive System Neoplasms Antineoplastic Agents Carcinoma, Hepatocellular Growth Substances Physiological Effects of Drugs Bevacizumab Angiogenesis Inhibitors Pharmacologic Actions |
Carcinoma Liver Neoplasms Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Adenocarcinoma Neoplasms, Glandular and Epithelial |