Axitinib as Second-line Treatment for Advanced Hepatocellular Carcinoma
This is a phase II study of axitinib as the second-line on the treatment of advanced hepatocellular carcinoma (HCC).
The purpose of this study is a proof-of-concept study to see if axitinib has any anti-tumor effect in HCC. The primary endpoint is disease stabilization that lasts for at least 8 weeks without progression of tumor-related symptoms.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Axitinib as Second-line Treatment for Advanced Hepatocellular Carcinoma|
- disease stabilization [ Time Frame: 8 weeks until tumor progression ] [ Designated as safety issue: Yes ]
- time-to-tumor progression [ Time Frame: 8 weeks until tumor progression ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2011|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
All enrolled patients will receive axitinib, 5 mg orally twice daily with food, until objective disease progression, development of unacceptable toxicity, or voluntary discontinuation by the subjects.
Other Name: Axitinib
Axitinib can can inhibit the activity of multiple angiogenesis-related signaling pathways. Promising anti-tumor activity has been demonstrated in patients with renal cell carcinoma, thyroid cancer, and melanoma. The potent anti-angiogenic activity of axitinib makes it a promising agent for the treatment of HCC.
This is a single-arm, open-label phase II trial. Eligible patients will receive axitinib, starting at 5 mg orally twice daily in the fasting status, until objective disease progression, development of unacceptable toxicity, or voluntary discontinuation. Dose titration will be done according to the severity of adverse events.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01273662
|National Taiwan University Hospital|
|Taipei City, Taiwan, 100|
|Taipei Veterans General Hospital|
|Taipei City, Taiwan, 11217|
|Tri-Service General Hospital|
|Taipei City, Taiwan, 114|
|Principal Investigator:||Ann-Lii Cheng, MD, PhD||Director/Professor|