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Brief Title: Axitinib as Second-line Treatment for Advanced Hepatocellular Carcinoma
Official Title: Axitinib as Second-line Treatment for Advanced Hepatocellular Carcinoma
Study ID: NCT01273662
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
National Taiwan University Hospital, Taipei City, , Taiwan
Taipei Veterans General Hospital, Taipei City, , Taiwan
Tri-Service General Hospital, Taipei City, , Taiwan
Name: Ann-Lii Cheng, MD, PhD
Affiliation: Director/Professor
Role: PRINCIPAL_INVESTIGATOR