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 2015|
|Estimated Primary Completion Date:||December 2014 (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.
|Contact: Ann-Lii Cheng, MD, PhD||886-2-23123456 ext firstname.lastname@example.org|
|Contact: Chiun Hsu, MD, PhD||886-2-23123456 ext email@example.com|
|National Taiwan University Hospital||Recruiting|
|Taipei City, Taiwan, 100|
|Contact: Ann-Lii Cheng, MD,PhD 886-2-23123456 ext 67251 firstname.lastname@example.org|
|Contact: Chiun Hsu, MD, PhD 886-2-23123456 ext 67009 email@example.com|
|Principal Investigator: Ann-Lii Cheng, MD, PhD|
|Sub-Investigator: Chiun Hsu, MD, PhD|
|Sub-Investigator: Chih-Hung Hsu, MD, PhD|
|Sub-Investigator: Zhong-Zhe Lin, MD|
|Sub-Investigator: Ying-Chun Shen, MD|
|Sub-Investigator: Ting-Fang Shih, MD|
|Taipei Veterans General Hospital||Recruiting|
|Taipei City, Taiwan, 11217|
|Contact: Yee Chao, MD, PhD 886-2-28757270 ext 7618 firstname.lastname@example.org|
|Principal Investigator: Yee Chao, MD, PhD|
|Tri-Service General Hospital||Recruiting|
|Taipei City, Taiwan, 114|
|Contact: Yeu-Chin Chen, MD 886-2-87927208 email@example.com|
|Principal Investigator: Yeu-Chin Chen, MD|
|Principal Investigator:||Ann-Lii Cheng, MD, PhD||Director/Professor|