Status:
COMPLETED
Trial for Hepatocellular Carcinoma Adjuvant Treatment by Lipiocis
Lead Sponsor:
ANRS, Emerging Infectious Diseases
Conditions:
Carcinoma, Hepatocellular
Hepatitis, Viral, Human
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 re...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT00116454
Start Date
July 1 2005
End Date
August 1 2013
Last Update
September 23 2013
Active Locations (1)
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1
Service d'Hépatologie Hôpital Saint Antoine
Paris, France, 75012