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Hepatocellular Carcinoma on Cirrhosis With Child A/B7 and Hepatic Intra Arterial Injection of Idarubicin/Lipiodol Emulsion
EU CTIS ID: 2024-515456-20-00
What this study is testing
Evaluate the disease control rate (partial, complete or stable response) 4 months after the first cycle of chemo-lipiodol using mRECIST criteria.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histologically-proven HCC or according to EASL criteria
- Absence of heart failure (Ultrasound LVEF > 50%)
- Women of child-bearing age using an adequate method of contraception throughout treatment and 6.5 months after treatment
- Men using an adequate method of contraception throughout the treatment and at least 3,5 months after the end of treatment
- Written informed consent
- National health insurance cover (France)
You likely can't join if
- Advanced tumor disease (extrahepatic except pulmonary micronodules <7mm of tumoral portal vein thrombosis on positron emission tomography are not a contra-indication.)
- Uncontrolled severe infection
- Vascular anatomy makes it impossible to perform hepatic intra-arterial treatments
- Grade 2 or 3 oesograstric varices on the last endoscopy less than 3 months old.
- Pregnancy (Beta HCG positive) or breastfeeding
- Patient who for psychological, social, family or geographical reasons cannot be followed regularly
See the full eligibility criteria
- Histologically-proven HCC or according to EASL criteria
- Absence of heart failure (Ultrasound LVEF > 50%)
- Women of child-bearing age using an adequate method of contraception throughout treatment and 6.5 months after treatment
- Men using an adequate method of contraception throughout the treatment and at least 3,5 months after the end of treatment
- Written informed consent
- National health insurance cover (France)
- 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
- Advanced tumor disease (extrahepatic except pulmonary micronodules <7mm of tumoral portal vein thrombosis on positron emission tomography are not a contra-indication.)
- Uncontrolled severe infection
- Vascular anatomy makes it impossible to perform hepatic intra-arterial treatments
- Grade 2 or 3 oesograstric varices on the last endoscopy less than 3 months old.
- 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.