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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
CCTU, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01352728
First received: May 11, 2011
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Chinese University of Hong Kong:

Primary Outcome Measures:
  • Two-year survival rate [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall confirmed objective response rate (ORR) as determined according to modified RECIST. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Disease Control Rate (DCR) [ Time Frame: 4 Years ] [ Designated as safety issue: No ]
  • Duration of Response (DR) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Time to Progression (TTP) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Progression-Free Survival (PFS) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Type, incidence, severity, timing, seriousness, and relatedness of adverse events and laboratory abnormalities [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Quality of Life [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Tissue and Serum Biomarkers [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: May 2011
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01352728

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

No publications provided

Responsible Party: CCTU, Comprehensive Clinical Trial Unit, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01352728     History of Changes
Other Study ID Numbers: HCC028
Study First Received: May 11, 2011
Last Updated: May 21, 2014
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by Chinese University of Hong Kong:
Unresectable

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on July 24, 2014