A Study of Avastin (Bevacizumab) and TACE Treatment in Patients With Liver Cancer.
This single arm, open label study will assess the efficacy and safety of Avastin treatment combined with transarterial chemoembolisation (TACE) in patients with localised unresectable liver cancer. Patients will be treated with TACE at 8 or 10 week intervals, and Avastin 5mg/kg iv will be administered 24-48 hours prior to first TACE and every 2 weeks thereafter. The anticipated time on study treatment is until disease progression or unmanageable toxicity, and the target sample size is <100 individuals.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label Study of the Effect of Avastin Pre- and Post-transarterial Chemoembolisation (TACE) Treatment on Progression-free Survival in Patients With Localized Unresectable Hepatocellular Carcinoma.|
- Progression-free survival [ Time Frame: Event driven ] [ Designated as safety issue: No ]
- Overall response rate, time to progression, disease control rate, overall survival, tumor necrosis rate. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
- AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
|Study Start Date:||February 2008|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|