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

• Sponsor: Chinese University of Hong Kong (Other)
• Overall Status: Completed
• CT.gov ID: NCT01352728
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arm: 1
• Actual Duration (Months): 84.7
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma	Drug: Axitinib	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Study of Transarterial Chemoembolisation and Axitinib for the Treatment of Unresectable Hepatocellular Carcinoma
• Actual Study Start Date: May 18, 2011
• Actual Primary Completion Date: Jun 7, 2018
• Actual Study Completion Date: Jun 7, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Two-year survival rate [4 years]

Secondary Outcome Measures

1. Overall confirmed objective response rate (ORR) as determined according to modified RECIST. [4 years]

2. Disease Control Rate (DCR) [4 Years]

3. Duration of Response (DR) [4 years]

4. Time to Progression (TTP) [4 years]

5. Progression-Free Survival (PFS) [4 years]

6. Overall survival (OS) [4 years]

7. Type, incidence, severity, timing, seriousness, and relatedness of adverse events and laboratory abnormalities [4 years]

8. Quality of Life [4 years]

9. Tissue and Serum Biomarkers [4 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

1. Diffuse-type HCC

2. Major surgery <4 weeks or radiation therapy <2 weeks of starting the study treatment.

3. Any form of prior transarterial therapy or systemic therapy for HCC.

4. Current use or anticipated need for treatment with drugs that are known potent CYP3A4 inhibitors or CYP3A4 or CYP1A2 inducers.

5. 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.

6. Any haemorrhage or bleeding event of CTCAE Grade 3 or more within 4 week

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Clinical Oncology, Prince of Wales Hospital	Hong Kong		Hong Kong

Sponsors and Collaborators

• Chinese University of Hong Kong

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: CCTU, Comprehensive Clinical Trial Unit, Chinese University of Hong Kong
• ClinicalTrials.gov Identifier: NCT01352728
• Other Study ID Numbers: HCC028
• First Posted: May 12, 2011
• Last Update Posted: Jun 20, 2018
• Last Verified: Jun 1, 2018

• Keywords provided by CCTU, Comprehensive Clinical Trial Unit, Chinese University of Hong Kong: Unresectable
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Axitinib

Study Results

No Results Posted as of Jun 20, 2018