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

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

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

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Drug: Axitinib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Two-year survival rate |  | 4 years | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Unresectable