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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
CCTU, Chinese University of Hong Kong Identifier:
First received: May 11, 2011
Last updated: July 5, 2017
Last verified: July 2017
The survival of subjects with unresectable hepatocellular carcinoma (HCC) receiving transarterial chemoembolization is improved with addition of axitinib.

Condition Intervention Phase
Hepatocellular Carcinoma Drug: Axitinib Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by CCTU, Chinese University of Hong Kong:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 50
Actual Study Start Date: May 18, 2011
Estimated Study Completion Date: May 31, 2018
Estimated Primary Completion Date: May 31, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TACE+Axitinib Drug: Axitinib
5 mg daily for 6 cycle with TACE+Axitinib, Axitinib continued until PD.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: CCTU, Comprehensive Clinical Trial Unit, Chinese University of Hong Kong Identifier: NCT01352728     History of Changes
Other Study ID Numbers: HCC028
Study First Received: May 11, 2011
Last Updated: July 5, 2017

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 processed this record on August 23, 2017