Hepatocellular Carcinoma
Conditions
Keywords
Unresectable
Brief summary
The survival of subjects with unresectable hepatocellular carcinoma (HCC) receiving transarterial chemoembolization is improved with addition of axitinib.
Interventions
DRUGAxitinib
5 mg daily for 6 cycle with TACE+Axitinib, Axitinib continued until PD.
Sponsors
Chinese University of Hong Kong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Two-year survival rate | 4 years |
Secondary
| Measure | Time frame |
|---|---|
| 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 confirmed objective response rate (ORR) as determined according to modified RECIST. | 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 |
| Overall survival (OS) | 4 years |
Countries
Hong Kong
Outcome results
None listed