Hepatocellular Carcinoma (HCC) Transarterial Chemoembolisation (TACE) +Axitinib

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01352728
Recruitment Status : Completed
First Posted : May 12, 2011
Last Update Posted : June 20, 2018
Information provided by (Responsible Party):
CCTU, Chinese University of Hong Kong

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

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: Axitinib Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Transarterial Chemoembolisation and Axitinib for the Treatment of Unresectable Hepatocellular Carcinoma
Actual Study Start Date : May 18, 2011
Actual Primary Completion Date : June 7, 2018
Actual Study Completion Date : June 7, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Axitinib

Arm Intervention/treatment
Experimental: TACE+Axitinib Drug: Axitinib
5 mg daily for 6 cycle with TACE+Axitinib, Axitinib continued until PD.

Primary Outcome Measures :
  1. Two-year survival rate [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. Overall confirmed objective response rate (ORR) as determined according to modified RECIST. [ Time Frame: 4 years ]
  2. Disease Control Rate (DCR) [ Time Frame: 4 Years ]
  3. Duration of Response (DR) [ Time Frame: 4 years ]
  4. Time to Progression (TTP) [ Time Frame: 4 years ]
  5. Progression-Free Survival (PFS) [ Time Frame: 4 years ]
  6. Overall survival (OS) [ Time Frame: 4 years ]
  7. Type, incidence, severity, timing, seriousness, and relatedness of adverse events and laboratory abnormalities [ Time Frame: 4 years ]
  8. Quality of Life [ Time Frame: 4 years ]
  9. Tissue and Serum Biomarkers [ Time Frame: 4 years ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01352728

Hong Kong
Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
Principal Investigator: Stephen L Chan, MRCP Chinese University of Hong Kong

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: CCTU, Comprehensive Clinical Trial Unit, Chinese University of Hong Kong Identifier: NCT01352728     History of Changes
Other Study ID Numbers: HCC028
First Posted: May 12, 2011    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018

Keywords provided by CCTU, Chinese University of Hong Kong:

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action