Trial for Hepatocellular Carcinoma Adjuvant Treatment by Lipiocis

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ANRS, Emerging Infectious Diseases; French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Treatments: Ethiodized Oil

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