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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01352728
• Other study ID #: HCC028
• Status: Completed
• Phase: Phase 2
• Start date: May 18, 2011
• Est. completion date: June 7, 2018

Study information

• Verified date: June 2018
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 7, 2018
• Est. primary completion date: June 7, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Axitinib
5 mg daily for 6 cycle with TACE+Axitinib, Axitinib continued until PD.

Locations

Country	Name	City	State
Hong Kong	Department of Clinical Oncology, Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

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