The research hypothesis is that hepatic locoregional treatment with idarubicin and lipiodol would be an effective adjuvant therapy of hepatocellular carcinoma
Conditions
Sponsors
University Hospital of Montpellier
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age = 18 years and = 80 years - Hepatopathy either histologically proven F3 or F4 stage, or with liver hardness measurements =10 kPa, either with suggestive morphological signs cirrhosis or portal hypertension viewed by medical Imaging - Child-Pugh score =B7 - Patients with these biological parameters : • platelets > 50 000/mm3 • neutrophils > 1000/mm3 • TP > 50% • creatininemia 50%) - Woman of childbearing age using a method of contraception for the duration of treatment and at least 3 months after the end of treatment. - Man using a method of contraception for the duration of treatment and at least 3 months after the end of treatment. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Pregnancy (determination of positive ßHCG) or breastfeeding according to article L1121-5 of the CSP. - Presence on the initial imaging result of a macroscopic vascular invasion (portal or superhepatic vein). - Presence on the initial imaging result of non-hepatic locations of hepatocellular carcinoma. - Other non treated cancer - Contraindication to general anaesthesia - Contraindication to MRI Exploration - Hypersensitivity to anthracyclines, iodine or gadolinium. - Contraindication to injection of gadolinium-based contrast media - Contraindication to injection of iodine-based contrast media - Contraindication to idarubicin - Contraindication to Lipiodol - Patients who have already received or exceeded the recommended cumulative dose for anthracyclines (idarubicin = 150 mg/m²). - Failure of endoscopic elimination of esophageal varices with level >1. - Inability to accede to the protocol - Patient who for psychological, social, family or geographical reasons could not be followed regularly - Vulnerable persons according to Article L1121-6 of the CSP - Concurrent patient participation in another research involving the human person. - Non-affiliation with or no beneficiary of a social security scheme (Article L.1121-11).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The secondary objectives are to compare, after percutaneous ablathermy of a hepatocellular carcinoma of less than 3 cm, the impact of an adjuvant intra arterial treatment with idarubicin-lipiodol versus the absence of adjuvant treatment on : -the hepatic tumour recurrence (local + intrahepatic distant) at 2 years - the local tumor recurrence at 1 and 2 years - the intrahepatic recurrence at a distance from the percutaneous tumoral destruction site at 1 and 2 years - the survival without hepatic recurrence at 2 years - the global survival;Main Objective: The main objective is to compare the survival rate without hepatic tumour recurrence (local and/or intrahepatic distant) 1 year after percutaneous ablathermia of a less than 3 cm hepatocellular carcinoma with an adjuvant intra-arterial treatment by idarubicin - lipiodol versus the absence of adjuvant treatment.;Primary end point(s): The primary end point is the survival rate without hepatic recurrence (local and/or intrahepatic) at 1 year.;Timepoint(s) of evaluation of this end point: At one year after the treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary end points are : • Accumulated rate of local hepatic recurrence at 1 and 2 years • Accumulated rate of distant intrahepatic recurrence at 1 and 2 years • Accumulated rate of hepatic recurrence (local and/or distant intrahepatic) at 1 and 2 years • Survival without hepatic recurrence in months between the randomization date and the date of hepatic MRI confirming hepatic recurrence • Survival rate without hepatic recurrence (local and/or distant intrahepatic) at 2 years • Overall survival in months from the randomization date to the date of the death of patient ;Timepoint(s) of evaluation of this end point: At 1 and/or 2 years after the treatment | — |
Countries
France
Contacts
Public ContactCadène Anne
University Hospital of Montpellier
Outcome results
None listed