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

Trial details

Who runs it

University Hospital, Montpellier

Trial code

NCT03727633

Record updated

31 March 2026

Original description

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.Read full original descriptionShow less

Traitement Des Carcinomes hépatocellulaires Sur Cirrhose Child A/B7 Par Injection Intra-artérielle hépatique d'Une émulsion de Lipiodol et Idarubicine : Etude de Phase II, Monobras, Multicentrique.

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.

Inclusion: 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: 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 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); Concomitant disease or uncontrolled severe clinical situation; Concomitant participation of the patient in another research involving the human person; Advanced tumor disease (extrahepatic except pulmonary micronodules <7mm of tumoral portal vein thrombosis on positron emission tomography are not a contra-indication.); 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 to the injection of the gadolinium-based contrast agents (history of hypersensibility to the gadolinium chelates, meglumine); Contra-indication to Lipiodol (Hypersensibility, proven hyperthyroidism, tromatic injuries, bleeding or recent bleeding); Uncontrolled severe infection; Large HCC with liver invasion >50%; 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.

ClinicalTrials.gov NCT03727633