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

  • STATUS
    Recruiting
  • End date
    May 8, 2024
  • participants needed
    53
  • sponsor
    University Hospital, Montpellier
Updated on 8 January 2022
cirrhosis
neutrophil count
arterial embolization
unresectable hepatocellular carcinoma
radioembolization

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.

Details
Condition Carcinoma, Hepatocellular
Treatment Idarubicin and Lipiodol
Clinical Study IdentifierNCT03727633
SponsorUniversity Hospital, Montpellier
Last Modified on8 January 2022

Eligibility

Yes No Not Sure

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
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