Trial for Hepatocellular Carcinoma Adjuvant Treatment by Lipiocis

Carcinoma, Hepatocellular Clinical Trial

— Lipiocis  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00116454
• Other study ID #: 2004-003883-31
• Secondary ID: ANRS HC06 LIPIOC
• Status: Completed
• Phase: Phase 3
• First received: June 29, 2005
• Last updated: September 20, 2013
• Start date: July 2005
• Est. completion date: August 2013

Study information

• Verified date: September 2013
• Source: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatitis, Viral, Human

Intervention

Drug:
• 131 I-lipiodol
intra-arterial hepatic administration of Lipiocis will occur, 11 to 12 weeks after the initial curative treatment

Locations

Country	Name	City	State
France	Service d'Hépatologie Hôpital Saint Antoine	Paris

Sponsors (1)

Lead Sponsor	Collaborator
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	overall survival		at 24 months	Yes
Secondary	recurrence-free survival		at 24 months	Yes
Secondary	treatment toxicity		at 24 months	Yes
Secondary	Deterioration of the hepatocellular function		at 24 months	Yes

External Links

•   Link