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Axitinib as Second-line Treatment for Advanced Hepatocellular Carcinoma

Phase 2
18 Years
Open (Enrolling)
Hepatocellular Carcinoma

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Trial Information

Axitinib as Second-line Treatment for Advanced Hepatocellular Carcinoma

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.

Inclusion Criteria:

- Histologically diagnosed HCC, OR clinically diagnosed HCC

- Inoperable tumor(s) and no applicable curative therapy. Not amenable to loco-regional

- 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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

disease stabilization

Outcome Time Frame:

8 weeks until tumor progression

Safety Issue:


Principal Investigator

Ann-Lii Cheng, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

April 2011

Completion Date:

December 2013

Related Keywords:

  • Hepatocellular Carcinoma
  • HCC
  • Carcinoma
  • Carcinoma, Hepatocellular