Hepatocellular Carcinoma (HCC) Transarterial Chemoembolisation (TACE) +Axitinib
Primary Purpose
Hepatocellular Carcinoma
Status
Completed
Phase
Phase 2
Locations
Hong Kong
Study Type
Interventional
Intervention
Axitinib
Sponsored by

About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Unresectable
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed HCC (or fulfilling AASLD criteria for HCC diagnosis in HBsAg positive subjects with cirrhosis in case biopsy is not feasible)
- Disease must not be amenable to potentially curative surgery
- Without prior systemic nor transarterial treatment
- Prior surgery or local therapy is allowed but the target lesion must have not been previously treated
- Child-Pugh stage A liver function
- ECOG performance 0-2
- Life expectancy longer than 12 weeks
- At least one measurable treatment lesion according to modified RECIST criteria
- Adequate haematological, hepatic and renal function
Exclusion Criteria:
Contra-indications to TACE treatment:
- Main portal vein thrombosis or occlusion
- Evidence of biliary obstruction
- Presence of extra-hepatic disease
- Diffuse-type HCC
- Major surgery <4 weeks or radiation therapy <2 weeks of starting the study treatment.
- Any form of prior transarterial therapy or systemic therapy for HCC.
- Current use or anticipated need for treatment with drugs that are known potent CYP3A4 inhibitors or CYP3A4 or CYP1A2 inducers.
- 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.
- Any haemorrhage or bleeding event of CTCAE Grade 3 or more within 4 week
Sites / Locations
- Department of Clinical Oncology, Prince of Wales Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TACE+Axitinib
Arm Description
Outcomes
Primary Outcome Measures
Two-year survival rate
Secondary Outcome Measures
Overall confirmed objective response rate (ORR) as determined according to modified RECIST.
Disease Control Rate (DCR)
Duration of Response (DR)
Time to Progression (TTP)
Progression-Free Survival (PFS)
Overall survival (OS)
Type, incidence, severity, timing, seriousness, and relatedness of adverse events and laboratory abnormalities
Quality of Life
Tissue and Serum Biomarkers
Full Information
NCT ID
NCT01352728
First Posted
May 11, 2011
Last Updated
June 19, 2018
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT01352728
Brief Title
Hepatocellular Carcinoma (HCC) Transarterial Chemoembolisation (TACE) +Axitinib
Official Title
A Phase II Study of Transarterial Chemoembolisation and Axitinib for the Treatment of Unresectable Hepatocellular Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
May 18, 2011 (Actual)
Primary Completion Date
June 7, 2018 (Actual)
Study Completion Date
June 7, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The survival of subjects with unresectable hepatocellular carcinoma (HCC) receiving transarterial chemoembolization is improved with addition of axitinib.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Unresectable
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TACE+Axitinib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Axitinib
Intervention Description
5 mg daily for 6 cycle with TACE+Axitinib, Axitinib continued until PD.
Primary Outcome Measure Information:
Title
Two-year survival rate
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Overall confirmed objective response rate (ORR) as determined according to modified RECIST.
Time Frame
4 years
Title
Disease Control Rate (DCR)
Time Frame
4 Years
Title
Duration of Response (DR)
Time Frame
4 years
Title
Time to Progression (TTP)
Time Frame
4 years
Title
Progression-Free Survival (PFS)
Time Frame
4 years
Title
Overall survival (OS)
Time Frame
4 years
Title
Type, incidence, severity, timing, seriousness, and relatedness of adverse events and laboratory abnormalities
Time Frame
4 years
Title
Quality of Life
Time Frame
4 years
Title
Tissue and Serum Biomarkers
Time Frame
4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed HCC (or fulfilling AASLD criteria for HCC diagnosis in HBsAg positive subjects with cirrhosis in case biopsy is not feasible)
Disease must not be amenable to potentially curative surgery
Without prior systemic nor transarterial treatment
Prior surgery or local therapy is allowed but the target lesion must have not been previously treated
Child-Pugh stage A liver function
ECOG performance 0-2
Life expectancy longer than 12 weeks
At least one measurable treatment lesion according to modified RECIST criteria
Adequate haematological, hepatic and renal function
Exclusion Criteria:
Contra-indications to TACE treatment:
Main portal vein thrombosis or occlusion
Evidence of biliary obstruction
Presence of extra-hepatic disease
Diffuse-type HCC
Major surgery <4 weeks or radiation therapy <2 weeks of starting the study treatment.
Any form of prior transarterial therapy or systemic therapy for HCC.
Current use or anticipated need for treatment with drugs that are known potent CYP3A4 inhibitors or CYP3A4 or CYP1A2 inducers.
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.
Any haemorrhage or bleeding event of CTCAE Grade 3 or more within 4 week
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen L Chan, MRCP
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Clinical Oncology, Prince of Wales Hospital
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Citations:
PubMed Identifier
28640364
Citation
Chan SL, Yeo W, Mo F, Chan AWH, Koh J, Li L, Hui EP, Chong CCN, Lai PBS, Mok TSK, Yu SCH. A phase 2 study of the efficacy and biomarker on the combination of transarterial chemoembolization and axitinib in the treatment of inoperable hepatocellular carcinoma. Cancer. 2017 Oct 15;123(20):3977-3985. doi: 10.1002/cncr.30825. Epub 2017 Jun 22.
Results Reference
derived
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Hepatocellular Carcinoma (HCC) Transarterial Chemoembolisation (TACE) +Axitinib
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