This trial is active, not recruiting.

Condition hepatocellular carcinoma
Treatment axitinib
Phase phase 2
Targets VEGF, PDGF
Sponsor Chinese University of Hong Kong
Start date May 2011
End date May 2017
Trial size 50 participants
Trial identifier NCT01352728, HCC028


The survival of subjects with unresectable hepatocellular carcinoma (HCC) receiving transarterial chemoembolization is improved with addition of axitinib.

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
5 mg daily for 6 cycle with TACE+Axitinib, Axitinib continued until PD.

Primary Outcomes

Two-year survival rate
time frame: 4 years

Secondary Outcomes

Overall confirmed objective response rate (ORR) as determined according to modified RECIST.
time frame: 4 years
Disease Control Rate (DCR)
time frame: 4 Years
Duration of Response (DR)
time frame: 4 years
Time to Progression (TTP)
time frame: 4 years
Progression-Free Survival (PFS)
time frame: 4 years
Overall survival (OS)
time frame: 4 years
Type, incidence, severity, timing, seriousness, and relatedness of adverse events and laboratory abnormalities
time frame: 4 years
Quality of Life
time frame: 4 years
Tissue and Serum Biomarkers
time frame: 4 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Histologically confirmed HCC (or fulfilling AASLD criteria for HCC diagnosis in HBsAg positive subjects with cirrhosis in case biopsy is not feasible) 2. Disease must not be amenable to potentially curative surgery 3. Without prior systemic nor transarterial treatment 4. Prior surgery or local therapy is allowed but the target lesion must have not been previously treated 5. Child-Pugh stage A liver function 6. ECOG performance 0-2 7. Life expectancy longer than 12 weeks 8. At least one measurable treatment lesion according to modified RECIST criteria 9. Adequate haematological, hepatic and renal function Exclusion Criteria: 1. Contra-indications to TACE treatment: - Main portal vein thrombosis or occlusion - Evidence of biliary obstruction - Presence of extra-hepatic disease 2. Diffuse-type HCC 3. Major surgery <4 weeks or radiation therapy <2 weeks of starting the study treatment. 4. Any form of prior transarterial therapy or systemic therapy for HCC. 5. Current use or anticipated need for treatment with drugs that are known potent CYP3A4 inhibitors or CYP3A4 or CYP1A2 inducers. 6. Requirement of anticoagulant therapy with oral vitamin K antagonists. Low dose anticoagulants for maintenance of patency of central venous access devise or prevention of deep venous thrombosis is allowed. Therapeutic use of low molecular weight heparin is allowed. 7. Any haemorrhage or bleeding event of CTCAE Grade 3 or more within 4 week

Additional Information

Official title A Phase II Study of Transarterial Chemoembolisation and Axitinib for the Treatment of Unresectable Hepatocellular Carcinoma
Principal investigator Stephen L Chan, MRCP
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Chinese University of Hong Kong.