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

Launched by UNIVERSITY HOSPITAL, MONTPELLIER · Oct 31, 2018

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for liver cancer, specifically hepatocellular carcinoma (HCC), in patients who have cirrhosis (scarring of the liver) and are not candidates for surgery. The treatment involves injecting a special chemotherapy drug called idarubicin mixed with Lipiodol directly into the liver. This method aims to target the cancer more effectively while minimizing harm to the rest of the body. The trial is currently looking for participants aged 18 and older who have been diagnosed with HCC but cannot undergo surgery or other standard treatments.

To be eligible for this trial, participants should have a confirmed diagnosis of HCC, a specific level of liver function (Child-Pugh A or B7), and must not have had any prior chemotherapy or radiation treatments. Participants can expect to receive the treatment in a medical setting and will be monitored closely for their response and any side effects. It’s important for potential participants to understand that they need to meet certain health criteria and will need to provide informed consent before joining the study.

Gender

ALL

Eligibility 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