Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT03727633
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03727633
Study Brief:
Protocol Section:
NCT03727633