NCT00116454

Brief Summary

The recurrence of hepatocellular carcinoma (HCC), two years after curative treatment is high, about 40% - 50%. Recently, it has been shown that intra-arterial radioactive lipiodol (Lipiocis®) could reduce the recurrence of cancer and increase the survival after resection of HCC developed on cirrhosis B. The aim of the present trial is to investigate the effect of Lipiocis® in preventing recurrence after curative treatment of HCC in patients with viral or alcoholic hepatitis related cirrhosis by surgical or percutaneous ablation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
73

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2005

Longer than P75 for phase_3

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

June 29, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 30, 2005

Completed
1 day until next milestone

Study Start

First participant enrolled

July 1, 2005

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

September 23, 2013

Status Verified

September 1, 2013

Enrollment Period

8.1 years

First QC Date

June 29, 2005

Last Update Submit

September 20, 2013

Conditions

Carcinoma, HepatocellularHepatitis, Viral, Human

Keywords

Carcinoma, HepatocellularViral Hepatitis, Alcoholic Hepatitis

Outcome Measures

Primary Outcomes (1)

  • to determine if the Lipiocis treatment decreases the % of tumoral recurrence after 24 months, judged on the rise of alpha-fetoprotein and the reappearance of one or more tumours on the hepatic CT scan

    at 24 Months

Secondary Outcomes (4)

  • overall survival

    at 24 months

  • recurrence-free survival

    at 24 months

  • treatment toxicity

    at 24 months

  • Deterioration of the hepatocellular function

    at 24 months

Study Arms (2)

lipiocis group

EXPERIMENTAL

intra-arterial hepatic administration, one 2200 MBQ dose, duration of treatment 1 week

Drug: 131 I-lipiodol

control group

NO INTERVENTION

group untreated

Interventions

131 I-lipiodolDRUG

intra-arterial hepatic administration of Lipiocis will occur, 11 to 12 weeks after the initial curative treatment

Also known as: Lipiocis
lipiocis group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men or women , aged between 18 and 75 years old
  • Cirrhosis or chronic hepatitis associated with C, B, delta infection or alcool intake or both and confirmed by liver biopsy
  • One or two HCC nodules treated by surgical or percutaneous ablation (ethanol, acetic acid 50% or radiofrequency).
  • The efficacy of the initial curative treatment will be assessed by the following criteria: alpha-fetoprotein concentration \< or equal 25ng/ml, no progression in size of the tumour demonstrated by ultrasonography and no arterial hypervascularization on CT scan imaging

You may not qualify if:

  • HIV coinfection associated with a CD count\<200/mm3 and a viral charge\>5000 HIV RNA copies/ml
  • Documented iodine intolerance
  • Respiratory insufficiency
  • Decompensated cirrhosis (Child-Pugh score over 8)
  • Bilirubin concentration over 51 µmol/l
  • Portal or hepatic vein thrombosis
  • Extra-hepatic metastasis
  • Excessive alcohol intake (over 50g per day)
  • Blood platelet count below 50000/mm3
  • Neutrophil count above 1500/mm3
  • Creatininemia over 120µmol/l
  • Myocardial infarction or rhythm disorders
  • Psychiatric disease with hospitalization
  • Previous treatment for hepatocellular carcinoma
  • Pregnant or breastfeeding
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service d'Hépatologie Hôpital Saint Antoine

Paris, 75012, France

Location

Related Links

MeSH Terms

Conditions

Carcinoma, HepatocellularHepatitis, Viral, HumanHepatitis, Alcoholic

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesVirus DiseasesInfectionsHepatitisLiver Diseases, AlcoholicAlcohol-Induced DisordersAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced Disorders

Study Officials

  • Olivier Rosmorduc, MD

    Hopital Saint Antoine SERVICE D'HEPATOLOGIE

    PRINCIPAL INVESTIGATOR

  • Fabrice Carrat, MD

    INSERM U 444 FACULTE DE MEDECINE ST ANTOINE

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2005

First Posted

June 30, 2005

Study Start

July 1, 2005

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

September 23, 2013

Record last verified: 2013-09

Locations

FR(1)