hepatocellular carcinoma on cirrhosis with child a/b7 and hepatic intra arterial injection of idarubicin/lipiodol emulsion

Conditions: Carcinoma, Hepatocellular

Summary: the investigators propose in this trial to test a hepatic chemotherapy, consisting of the hepatic intra-arterial injection idarubicin, emulsified with lipiodol, lipid vector, without embolization in the treatment of non-metastatic, unresectable hepatocellular carcinoma on cirrhosis with child-pugh a/b7.


Eligibility criteria:
inclusion criteria: * histologically-proven hcc or according to easl criteria * child-pugh a or b7 * disease that is not suitable for resection, ablation or radiofrequency * performance status ecog 0 or 1 * bclc a/b or c if performance status ecog = 1 * measurable lesions according to mrecist criteria * no previous treatment with chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy) or radioembolisation * age superior or equal to 18 years * platelets \> 50,000/mm3, polynuclear neutrophils \> 1000/mm3, creatininemia \< 150umol/l, bilirubinemia \< 5 mg/dl * absence of heart failure (ultrasound lvef \> 50%) * women of child-bearing age using an adequate method of contraception throughout treatment * men using an adequate method of contraception throughout the treatment and at least 3 months after the end of treatment * written informed consent * national health insurance cover exclusion criteria: * advanced tumor disease (extrahepatic except pulmonary micronodules \<7mm of tumoral portal vein thrombosis on positron emission tomography are not a contra-indication.) * large hcc with liver invasion \>50% * history of other cancer than hcc and excluding cancers known to have been cured for more than 5 years, or basocellular skin tumors or cervical cancer in situ treated with adequate and curative purpose * advanced liver disease (child b8, b9 or c) * contra-indication for the mri (pacemaker or neurosensorial stimulator or implantable defibrillator, cochlear implant, ferromagnetic foreing body similar to the nervous structure) * contra-indication to the injection of the gadolinium-based contrast agents (history of hypersensibility to the gadolinium chelates, meglumine). * contra-indication to idarubicin (hypersensibility to active substance or excipients, cardiopathy with myocardial insufficiency of less than 6 months, serious arrhythmias, serious renal or liver failure, yellow fever vaccine or any other live attenuated vaccine, persistente myelosuppression, previous treatments with idarubicin and/or other anthracyclines or anthracenediones at maximum cumulative doses, stomatitis) * contra-indication to lipiodol (hypersensibility, proven hyperthyroidism, tromatic injuries, bleeding or recent bleeding) * concomitant disease or uncontrolled severe clinical situation * uncontrolled severe infection * vascular anatomy makes it impossible to perform hepatic intra-arterial treatments * pregnancy (beta hcg positive) or breastfeeding * patient who for psychological, social, family or geographical reasons cannot be followed regularly * vulnerable person * concomitant participation of the patient in another research involving the human person