NCT00467974

Brief Summary

The current randomized controlled trial comparing LEM and TACE aims to evaluate the safety and efficacy of LEM as compared to TACE for treating patients with unresectable HCC.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
98

participants targeted

Target at below P25 for phase_3 hepatocellular-carcinoma

Timeline
Completed

Started Jun 2007

Longer than P75 for phase_3 hepatocellular-carcinoma

Geographic Reach
1 country

3 active sites

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

April 30, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 1, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2007

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

January 26, 2015

Status Verified

December 1, 2014

Enrollment Period

7.4 years

First QC Date

April 30, 2007

Last Update Submit

January 21, 2015

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (2)

  • overall survival

    3 years

  • progression free survival

    3 years

Secondary Outcomes (5)

  • tumor response

    4 weeks after end of treatment

  • rate of conversion to resectable stage

    4 weeks after end of treatment

  • toxicity of treatment

    4 weeks after end of treatment

  • quality of life

    up to one year after randomisation

  • consumption of hospital resources

    3 years

Study Arms (2)

1

EXPERIMENTAL

TEA with LEM

Procedure: TEA with LEM

2

ACTIVE COMPARATOR

TACE

Procedure: TACE

Interventions

TEA with LEMPROCEDURE

Transarterial ethanol ablation (TEA) with Lipiodol-ethanol mixture (LEM)

1
TACEPROCEDURE

Transarterial chemoembolisation (TACE)

2

Eligibility Criteria

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

You may qualify if:

  • Patient factor
  • Age \> 18
  • Child-Pugh A or B cirrhosis
  • ECOG performance status Grade 2 or below
  • No serious concurrent medical illness
  • No prior treatment (including surgery) for HCC
  • Tumor factor
  • Histologically or cytologically proven HCC (an alphafetoprotein level \> 500 ug/ml in the presence of radiological findings suggestive of HCC in a patient with chronic HBV or HCV infection can be considered eligible at investigator's discretion)
  • Unresectable and locally advanced disease without extra-hepatic disease
  • Massive expansive or nodular tumor morphology with measurable lesion on CT
  • Size of largest tumor \<= 15cm in largest dimension
  • Number of main tumor \<= 5, excluding associated small satellite lesions.

You may not qualify if:

  • Patient factor
  • History of prior malignancy except skin cancer
  • History of significant concurrent medical illness such as ischemic heart disease or heart failure
  • History of acute tumor rupture
  • Serum creatinine level \> 180 umol/L
  • Presence of biliary obstruction not amenable to percutaneous drainage
  • Child-Pugh C cirrhosis
  • Evidence of poor liver function
  • History of hepatic encephalopathy, or
  • Intractable ascites not controllable by medical therapy, or
  • History of variceal bleeding within last 3 months, or
  • Serum total bilirubin level \> 50 umol/L, or
  • Serum albumin level \< 28g/L, or
  • INR \> 1.3
  • Tumor factor
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Department of Clinical Oncology, Prince of Wales Hospital, The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

Department of Diagnostic Radiology and Organ Imaging, Prince of Wales Hospital, The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (1)

  • Yu SC, Hui JW, Hui EP, Chan SL, Lee KF, Mo F, Wong J, Ma B, Lai P, Mok T, Yeo W. Unresectable hepatocellular carcinoma: randomized controlled trial of transarterial ethanol ablation versus transcatheter arterial chemoembolization. Radiology. 2014 Feb;270(2):607-20. doi: 10.1148/radiol.13130498. Epub 2013 Oct 28.

    PMID: 24126369DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Tealeukocyte endogenous mediator

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Simon CH Yu, MD, FRCR

    Department of Diagnostic Radiology and Organ Imaging, Prince of Wales Hospital, The Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

April 30, 2007

First Posted

May 1, 2007

Study Start

June 1, 2007

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

January 26, 2015

Record last verified: 2014-12

Locations

HK(3)