Hepatocellular Carcinoma on Cirrhosis With Child A/B7 and Hepatic Intra Arterial Injection of Idarubicin/Lipiodol Emulsion (LIDA-BII)

University Hospital Center (CHU)

Status and phase: Enrolling; Phase 2

Conditions: Carcinoma, Hepatocellular

Treatments: Drug: Idarubicin and Lipiodol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03727633

UF 9888 (Other Identifier)

RECHMPL17_0304

2017-004859-22 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 53 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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53 participants in 1 patient group

Treatment arm

Experimental group

Description:

hepatic intra-arterial injection of an emulsion of Idarubicine and Lipiodol

Treatment:

Drug: Idarubicin and Lipiodol