This trial is active, not recruiting.

Condition hepatocellular carcinoma
Treatment ag-013736
Phase phase 2
Targets VEGF, PDGF
Sponsor National Taiwan University Hospital
Collaborator Tri-Service General Hospital
Start date April 2011
End date July 2016
Trial size 45 participants
Trial identifier NCT01273662, 201008013M


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
ag-013736 Axitinib
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.

Primary Outcomes

disease stabilization
time frame: 8 weeks until tumor progression

Secondary Outcomes

time-to-tumor progression
time frame: 8 weeks until tumor progression

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Histologically diagnosed HCC, OR clinically diagnosed HCC - Inoperable tumor(s) and no applicable curative therapy. Not amenable to loco-regional therapy - Documented progression with or intolerance to sorafenib treatment as first- line therapy for advanced HCC - At least one measurable tumor, according to RECIST version 1.1, that has not been treated with any local procedure - ECOG performance status 0 or 1 - Life expectancy is at least 2 months - Child-Pugh class A liver function. Exclusion Criteria: - Systemic therapy other than sorafenib as first-line therapy for advanced HCC - History of HCC tumor rupture - Presence of brain or leptomeningeal metastases - Esophageal/gastric varices or active peptic ulcers that are considered to have high risk of bleeding - History of upper gastrointestinal bleeding within 1 year - Major systemic diseases that the investigator considers inappropriate for participation - Uncontrollable hypertension - Proteinuria - Current use or anticipated need for treatment with potent CYP3A4 inhibitor, CYP3A4 or CYP1A2 inducers - Requirement of anticoagulant therapy with oral vitamin K antagonists - Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol - Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation and in the judgment of the investigator would make the patient inappropriate for entry into this study

Additional Information

Official title Axitinib as Second-line Treatment for Advanced Hepatocellular Carcinoma
Principal investigator Ann-Lii Cheng, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by National Taiwan University Hospital.