AVATACE-1: Bevacizumab (Avastin®) as Inhibitor of Collateral Tumor Vessel Growth During Transarterial Chemoembolisation (TACE) for Hepatocellular Carcinoma (HCC) a Pilot Trial
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
- to assess the effectiveness of bevacizumab in combination with TACE as measured by
patients without tumor progression on MRT after 3 cycles of TACE as well as the number
of TACE cycles applied for recurrent tumor after a maximum of one year treatment with
bevacizumab
- to assess collateral tumor vessel growth on MRT / CT
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
to assess the effectiveness of bevacizumab in combination with TACE as measured by patients without tumor progression after a maximum of one year treatment with bevacizumab
12 months
No
Markus Peck-Radosavljevic, M.D.
Principal Investigator
Medizinische Universität Wien
Austria: Federal Ministry for Health and Women
MPR-2
NCT00280007
January 2006
December 2010
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