Hepatocellular Carcinoma on Cirrhosis With Child A/B7 and Hepatic Intra Arterial Injection of Idarubicin/Lipiodol Emulsion
- Registration Number
- NCT03727633
- Lead Sponsor
- University Hospital, Montpellier
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 53
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment arm Idarubicin and Lipiodol hepatic intra-arterial injection of an emulsion of Idarubicine and Lipiodol
- Primary Outcome Measures
Name Time Method Percentage of participants presenting a disease control at 4 months 4 months The primary outcome is to evaluate the disease control rate (partial, complete or stable response) 4 months after the first cycle of chemo-lipiodol using mRECIST criteria.
- Secondary Outcome Measures
Name Time Method Quality of life questionnaire (QLQ) QLQ-C30 12 months Quality of life questionnaire at 12 months after the first cycle of chemo-lipiodol (QLQ-C30). Subscale minimum score is egal to 1 (not at all) and maximum score is egal to 4 (very much). The maximal score correspond to a better quality of life. Subscales are summed to compute a total score.
Objective response rate of chemo-lipiodol 6 months Objective response rate according to mRECIST at 6 months after the first cycle
Safety of chemo-lipiodol defined by NCI-CTCAE version 4.03 12 months Safety defined by NCI-CTCAE version 4.03 published 14 june 2010
best response at 6 months after the first cycle of chemo-lipiodol according to mRECIST 6 months The best response according to mRECIST at 6 months after the first cycle of chemo-lipiodol
Overall survival 12 months Overall survival at 12 months after the first cycle of chemo-lipiodol
Trial Locations
- Locations (4)
CHU d'Angers
🇫🇷Angers, France
CHU de Dijon
🇫🇷Dijon, France
CHU de Nice
🇫🇷Nice, France
CHU de Montpellier
🇫🇷Montpellier, France