Axitinib for the treatment of advanced hepatocellular carcinoma

A multicenter, global, randomized, double - blind study of axitinib plus best supportive care versus placebo plus best supportive care in patients with advanced hepatocellular carcinoma following failure of one prior antiangiogenic therapy(A4061058)

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221284

Enrollment

222

Registered

2010-10-26

Start date

2010-10-26

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Interventions

investigational material(s) Generic name etc : Axitinib (AG-013736) INN of investigational material : Axitinib Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Inve

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Locally advanced or metastatic HCC - Failure of one prior antiangiogenic therapy including sorafenib, bevacizumab and brivanib. - Child-Pugh Class A or B (score 7 only) disease.

Exclusion criteria

Exclusion criteria: - Prior treatment of advanced HCC with more than one prior first-line systemic therapy. - Any prior local therapy within 2 weeks of study screening. - Prior history of liver transplant. - Presence of hepatic encephalopathy and/or clinically relevant ascites. - Presence of main portal vein invasion by HCC.

Design outcomes

Primary

Measure	Time frame
Overall Survival	—

Secondary

Measure	Time frame
Progression-Free Survival Time to Tumor Progression Overall Response Rate Duration of Response Clinical Benefit Response Safety and tolerability Pharmacokinetics HRQoL	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026