Trial for Hepatocellular Carcinoma Adjuvant Treatment by Lipiocis (Lipiocis)

September 20, 2013 updated by: ANRS, Emerging Infectious Diseases

A Randomized and Multicenter Trial for Hepatocellular Carcinoma Adjuvant Treatment by Lipiocis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The usual therapeutic approaches of early hepatocellular carcinoma (HCC) are partial hepatectomy or percutaneous ethanol injection. However, these therapeutic procedures do not suppress the cirrhotic liver tissue which represents a major risk factor for recurrence and/or occurrence of a second tumor in the liver. 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 randomized and multicenter trial is to investigate the effect of iodine-131-labelled lipiodol (131I-lipiodol = Lipiocis®) in preventing recurrence after curative treatment of HCC (hepatocellular carcinoma) in patients with viral or alcoholic hepatitis related cirrhosis by surgical or percutaneous ablation. The period of this study will be 3 years including 1 year for the enrollment and 2 years for the follow-up. Fifty patients will receive one 2200 MBq dose of Lipiocis and 50 patients will not be treated by Lipiocis (control group). The intra-arterial hepatic administration of Lipiocis will occur 11 to 12 weeks after the initial curative treatment.

The inclusion criteria are as follows : 1) men or women, aged between 18 and 75 years old, with cirrhosis or chronic hepatitis associated with C, B, delta infection or alcool intake or both and confirmed by liver biopsy and 2) 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 below 25ng/ml, no progression in size of the tumour demonstrated by ultrasonography and no arterial hypervascularization on CT scan imaging.

The patients with the following criteria will be excluded: co-infection with HIV (Human Immunodeficiency Virus)associated with a CD count <200/mm3 and a viral charge >5000 HIV RNA copies/ml, documented iodine intolerance, respiratory disease, decompensated cirrhosis (Child-Pugh score over or equal 8), bilirubin concentration over 51µmol/l, portal or hepatic vein thrombosis, extra-hepatic metastasis, excessive alcohol intake (over 50g per day), blood platelet count below 50,000/mm3, neutrophil count below 1500/mm3, creatininemia over 120µmol/l, other severe concurrent disease, previous treatment for hepatocellular carcinoma and women who can be pregnant or breastfeeding.

The main endpoint will be to determine whether the Lipiocis® treatment reduces the percentage of recurrence from 50% to 20% at 24 months. The secondary end-points will be the overall survival, the survival without recurrence of the primary tumor, the survival without new tumor, the deterioration of hepatocellular function and the side effects of the Lipiocis® treatment.

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75012
        • Service d'Hépatologie Hôpital Saint Antoine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Treatment with interferon and/or ribavirin 3 months before inclusion
  • Treatment with tamoxifen or somatostatin analogs or systemic chemotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: lipiocis group
intra-arterial hepatic administration, one 2200 MBQ dose, duration of treatment 1 week
Drug: 131 I-lipiodol
intra-arterial hepatic administration of Lipiocis will occur, 11 to 12 weeks after the initial curative treatment
Other Names:
  • Lipiocis
No Intervention: control group
group untreated

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: at 24 Months
at 24 Months

Secondary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: at 24 months
at 24 months
recurrence-free survival
Time Frame: at 24 months
at 24 months
treatment toxicity
Time Frame: at 24 months
at 24 months
Deterioration of the hepatocellular function
Time Frame: at 24 months
at 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ANRS, Emerging Infectious Diseases

Investigators

  • Principal Investigator: Olivier Rosmorduc, MD, Hopital Saint Antoine SERVICE D'HEPATOLOGIE
  • Study Director: Fabrice Carrat, MD, INSERM U 444 FACULTE DE MEDECINE ST ANTOINE

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

June 29, 2005

First Submitted That Met QC Criteria

June 29, 2005

First Posted (Estimate)

June 30, 2005

Study Record Updates

Last Update Posted (Estimate)

September 23, 2013

Last Update Submitted That Met QC Criteria

September 20, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2004-003883-31
  • ANRS HC06 LIPIOCIS (Other Identifier: ANRS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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