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Sponsored by: |
Medical University of Vienna |
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Information provided by: | Medical University of Vienna |
ClinicalTrials.gov Identifier: | NCT00280007 |
Patients with liver cirrhosis and hepatocellular carcinoma will undergo transarterial chemoembolisation (TACE) as clinically indicated and will be randomized to receive bevacizumab or placebo every 2 weeks up to 1 year. Tumor response will be assessed using MR of the liver and PET-scanning.
It will be tested whether the addition of bevacizumab as angiogenic inhibitor will slow down tumor progression, reduce the need for reembolisation and will improve patient survival.
Condition | Intervention | Phase |
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Hepatocellular Carcinoma |
Drug: bevacizumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | AVATACE-1: Bevacizumab (Avastin®) as Inhibitor of Collateral Tumor Vessel Growth During Transarterial Chemoembolisation (TACE) for Hepatocellular Carcinoma (HCC) a Pilot Trial |
Estimated Enrollment: | 40 |
Study Start Date: | January 2006 |
TACE is an established therapy for patients with advanced stage HCC not amenable to liver transplantation or resection and has been shown to significantly improve survival in these patients compared to no treatment (8). TACE takes advantage of the predominantly arterial blood supply of malignant liver tumors contrary to the surrounding normal liver tissue, which receives more blood supply through the portal venous system.
TACE leads to predictable tumor necrosis until new blood vessels grow into the tumor margins to support tumor growth. Quite often after cutting off the blood supply through the hepatic artery, the tumor induces active angiogenesis to promote collateral blood vessel growth from liver capsule arteries or collaterals from the gastroduodenal artery. VEGF seems to be an important player in inducing this angiogenetic activity and tumor control and survival of patients after TACE have been linked to serum VEGF-levels with higher levels showing reduced survival.
Inhibition of these neoangiogenetic activity could lead to significantly improved in tumor control and survival in patients with advanced stage HCC.
2. STUDY OBJECTIVE
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Proteinuria at baseline:
Haematology:
Biochemistry:
Exclusion Criteria:
Contact: Markus Peck-Radosavljevic, M.D. | +43 1 40400 ext 6589 | markus.peck@meduniwien.ac.at |
Contact: Gregor Ulbrich, M.D. | +43 1 40400 ext 6589 | gregor.ulbrich@meduniwien.ac.at |
Austria | |
Medizinische Universität Wien | Recruiting |
Vienna, Austria, A-1090 | |
Principal Investigator: Markus Peck-Radosavljevic, M.D. | |
Sub-Investigator: Gregor Ulbrich, M.D. |
Principal Investigator: | Markus Peck-Radosavljevic, M.D. | Medizinische Universität Wien |
Study ID Numbers: | MPR-2 |
Study First Received: | January 19, 2006 |
Last Updated: | September 7, 2006 |
ClinicalTrials.gov Identifier: | NCT00280007 |
Health Authority: | Austria: Federal Ministry for Health and Women |
hepatocellular carcinoma TACE transarterial chemoembolisation portal hypertension |
angiogenesis VEGF bevacizumab |
Liver Diseases Digestive System Neoplasms Carcinoma, Hepatocellular Liver neoplasms Bevacizumab Hypertension, Portal Portal hypertension Carcinoma |
Liver Neoplasms Digestive System Diseases Gastrointestinal Neoplasms Adenocarcinoma Hypertension Neoplasms, Glandular and Epithelial Hepatocellular carcinoma |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Antineoplastic Agents Therapeutic Uses Growth Substances |
Physiological Effects of Drugs Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |