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

• Status: Recruiting
• Trial end date: 2024-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Montpellier
• Collaborator: Guerbet
• Treatments: Ethiodized Oil; Idarubicin

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