NCT01352728

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_2 hepatocellular-carcinoma

Timeline
Completed

Started May 2011

Longer than P75 for phase_2 hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 12, 2011

Completed
6 days until next milestone

Study Start

First participant enrolled

May 18, 2011

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2018

Completed
Last Updated

June 20, 2018

Status Verified

June 1, 2018

Enrollment Period

7.1 years

First QC Date

May 11, 2011

Last Update Submit

June 19, 2018

Conditions

Hepatocellular Carcinoma

Keywords

Unresectable

Outcome Measures

Primary Outcomes (1)

  • Two-year survival rate

    4 years

Secondary Outcomes (9)

  • 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

  • +4 more secondary outcomes

Study Arms (1)

TACE+Axitinib

EXPERIMENTAL
Drug: Axitinib

Interventions

AxitinibDRUG

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

TACE+Axitinib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Oncology, Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Related Publications (1)

  • 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.

    PMID: 28640364DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Axitinib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsIndazolesPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Stephen L Chan, MRCP

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Comprehensive Clinical Trial Unit

Study Record Dates

First Submitted

May 11, 2011

First Posted

May 12, 2011

Study Start

May 18, 2011

Primary Completion

June 7, 2018

Study Completion

June 7, 2018

Last Updated

June 20, 2018

Record last verified: 2018-06

Locations

HK(1)