Clinical trial NCT01352728: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Keywords: Unresectable
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2011-05-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Two-year survival rate
timeFrame: 4 years
Secondary outcomes:
measure: Overall confirmed objective response rate (ORR) as determined according to modified RECIST.
timeFrame: 4 years
measure: Disease Control Rate (DCR)
timeFrame: 4 Years
measure: Duration of Response (DR)
timeFrame: 4 years
measure: Time to Progression (TTP)
timeFrame: 4 years
measure: Progression-Free Survival (PFS)
timeFrame: 4 years
measure: Overall survival (OS)
timeFrame: 4 years
measure: Type, incidence, severity, timing, seriousness, and relatedness of adverse events and laboratory abnormalities
timeFrame: 4 years
measure: Quality of Life
timeFrame: 4 years
measure: Tissue and Serum Biomarkers
timeFrame: 4 years
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Clinical Oncology, Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Stephen L Chan, MRCP
role: PRINCIPAL_INVESTIGATOR
References:
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.