Trial for Hepatocellular Carcinoma Adjuvant Treatment by Lipiocis
Condition: Carcinoma, Hepatocellular; Hepatitis, Viral, Human
MeSH terms: Hepatitis, Viral, Human; Carcinoma; Carcinoma, Hepatocellular; Hepatitis
Study type: Interventional
Phase: Phase 3

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.
    

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.
    

Intervention name(s): 131 I-lipiodol
Intervention type(s): Drug
Intervention description(s): intra-arterial hepatic administration of Lipiocis will occur, 11 to 12 weeks after the initial curative treatment
Other intervention name(s): Lipiocis
Intervention MeSH terms: Ethiodized Oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Carcinoma, Hepatocellular; Viral Hepatitis, Alcoholic Hepatitis