Trial for Hepatocellular Carcinoma Adjuvant Treatment by Lipiocis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier:
NCT00116454
First received: June 29, 2005
Last updated: September 20, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Carcinoma, Hepatocellular
Hepatitis, Viral, Human
Drug: 131 I-lipiodol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized and Multicenter Trial for Hepatocellular Carcinoma Adjuvant Treatment by Lipiocis

Resource links provided by NLM:


Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: at 24 months ] [ Designated as safety issue: Yes ]
  • recurrence-free survival [ Time Frame: at 24 months ] [ Designated as safety issue: Yes ]
  • treatment toxicity [ Time Frame: at 24 months ] [ Designated as safety issue: Yes ]
  • Deterioration of the hepatocellular function [ Time Frame: at 24 months ] [ Designated as safety issue: Yes ]

Enrollment: 73
Study Start Date: July 2005
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Lipiocis
No Intervention: control group
group untreated

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00116454

Locations
France
Service d'Hépatologie Hôpital Saint Antoine
Paris, France, 75012
Sponsors and Collaborators
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
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
  More Information

Additional Information:
No publications provided

Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier: NCT00116454     History of Changes
Other Study ID Numbers: 2004-003883-31, ANRS HC06 LIPIOCIS
Study First Received: June 29, 2005
Last Updated: September 20, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
Carcinoma, Hepatocellular
Viral Hepatitis, Alcoholic Hepatitis

Additional relevant MeSH terms:
Carcinoma
Hepatitis
Hepatitis A
Hepatitis, Viral, Human
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on April 15, 2014