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

June 19, 2018 updated by: CCTU, Chinese University of Hong Kong

A Phase II Study of Transarterial Chemoembolisation and Axitinib for the Treatment of Unresectable Hepatocellular Carcinoma

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Department of Clinical Oncology, Prince of Wales Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Two-year survival rate
Time Frame: 4 years
4 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Stephen L Chan, MRCP, Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 18, 2011

Primary Completion (Actual)

June 7, 2018

Study Completion (Actual)

June 7, 2018

Study Registration Dates

First Submitted

May 11, 2011

First Submitted That Met QC Criteria

May 11, 2011

First Posted (Estimate)

May 12, 2011

Study Record Updates

Last Update Posted (Actual)

June 20, 2018

Last Update Submitted That Met QC Criteria

June 19, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCC028

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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