Informations générales (source: ClinicalTrials.gov)
Traitement Des Carcinomes hépatocellulaires Sur Cirrhose Child A/B7 Par Injection Intra-artérielle hépatique d'Une émulsion de Lipiodol et Idarubicine : Etude de Phase II, Monobras, Multicentrique. (LIDA-BII)
Interventional
Phase 2
University Hospital, Montpellier (Voir sur ClinicalTrials)
juillet 2018
janvier 2026
05 avril 2025
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHU d'Angers - 49933 - Angers - France | Christophe AUBE, PH | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU de Dijon - 21079 - Dijon - France | Romaric LOFFROY, PH | Contact (sur clinicalTrials) | |||
| CHU de Montpellier - 34295 - Montpellier - France | Boris GUIU, PUPH | Contact (sur clinicalTrials) | |||
| CHU de Nice - 06202 - Nice - France | Patrick CHEVALLIER, PH | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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