Transarterial Chemoembolisation Plus Bevacizumab for Treatment of Hepatocellular Carcinoma

Sponsor
Medical University of Vienna
Study ID
NCT00280007
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab — DRUG
    bevacizumab 5 mg/kg i.v. every 14 days for 52 weeks

Study Details

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 re-embolisation and will improve patient survival.

Key Dates

First listed
Jan 20, 2006
Start date
Jan 31, 2006
Status verified
Sep 2009
Primary completion
Dec 31, 2009
Completion
Dec 31, 2010

Study Design

Enrollment
32 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    bevacizumab infusion evey 2 weeks
  • Placebo Comparator: 2
    placebo infusion

Primary Outcome Measure

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 [ Time Frame: 12 months ]

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