Hepatocellular Carcinoma on Cirrhosis With Child A/B7 and Hepatic Intra Arterial Injection of Idarubicin/Lipiodol Emulsio

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 53

Inclusion Criteria

Histologically-proven HCC or according to EASL criteria, Absence of heart failure (Ultrasound LVEF > 50%), Women of child-bearing age using an adequate method of contraception throughout treatment and 6.5 months after treatment, Men using an adequate method of contraception throughout the treatment and at least 3,5 months after the end of treatment, Written informed consent, National health insurance cover (France), 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/d

Exclusion Criteria

Advanced tumor disease (extrahepatic except pulmonary micronodules <7mm of tumoral portal vein thrombosis on positron emission tomography are not a contra-indication.), Uncontrolled severe infection, Vascular anatomy makes it impossible to perform hepatic intra-arterial treatments, Grade 2 or 3 oesograstric varices on the last endoscopy less than 3 months old., 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, 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluate the disease control rate (partial, complete or stable response) 4 months after the first cycle of chemo-lipiodol using mRECIST criteria.;Secondary Objective: Treatment safety, Objective response rate according to mRECIST at 6 months after the first cycle, The best response according to mRECIST at 6 months after the first cycle of chemo-lipiodol, Overall survival at 12 months after the first cycle of chemo-lipiodol, Overall survival without progression of the deasese, Quality of life questionnaire at 12 months after the first cycle of chemo-lipiodol., Arterial liver thrombosis/sténosis artérielle hépatique after each cycle of chemo-lipiodol;Primary end point(s): Disease control rate (partial, complete or stable response) at 4 months after the first cycle of chemo-lipiodol using mRECIST criteria.

Secondary Outcome Measures