LIDA-BII: Hepatocellular Carcinoma on Cirrhosis With Child A/B7 and Hepatic Intra Arterial Injection of Idarubicin/Lipiodol Emulsion
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Treatment arm hepatic intra-arterial injection of an emulsion of Idarubicine and Lipiodol |
Drug: Idarubicin and Lipiodol
Hepatic intra-arterial chemotherapy consisting of the hepatic intra-arterial injection Idarubicin, emulsified with Lipiodol
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- Objective response rate of chemo-lipiodol [6 months]
Objective response rate according to mRECIST at 6 months after the first cycle
- 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
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Histologically-proven HCC or according to EASL criteria
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Child-Pugh A or B7
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Disease that is not suitable for resection, ablation or radiofrequency
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Performance Status ECOG 0 or 1
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BCLC A/B or C if Performance Status ECOG = 1
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Measurable lesions according to mRECIST criteria
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No previous treatment with chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy) or radioembolisation
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Age superior or equal to 18 years
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Platelets > 50,000/mm3, Polynuclear neutrophils > 1000/mm3, Creatininemia < 150umol/L, Bilirubinemia < 5 mg/dL
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Absence of heart failure (Ultrasound LVEF > 50%)
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Women of child-bearing age using an adequate method of contraception throughout treatment
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Men using an adequate method of contraception throughout the treatment and at least 3 months after the end of treatment
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Written informed consent
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National health insurance cover
Exclusion Criteria:
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Advanced tumor disease (extrahepatic except pulmonary micronodules <7mm of tumoral portal vein thrombosis on positron emission tomography are not a contra-indication.)
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Large HCC with liver invasion >50%
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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
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Advanced liver disease (Child B8, B9 or C)
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Contra-indication for the MRI (Pacemaker or neurosensorial stimulator or implantable defibrillator, cochlear implant, ferromagnetic foreing body similar to the nervous structure)
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Contra-indication to the injection of the gadolinium-based contrast agents (history of hypersensibility to the gadolinium chelates, meglumine).
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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)
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Contra-indication to Lipiodol (Hypersensibility, proven hyperthyroidism, tromatic injuries, bleeding or recent bleeding)
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Concomitant disease or uncontrolled severe clinical situation
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Uncontrolled severe infection
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Vascular anatomy makes it impossible to perform hepatic intra-arterial treatments
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Pregnancy (Beta HCG positive) or breastfeeding
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Patient who for psychological, social, family or geographical reasons cannot be followed regularly
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Vulnerable person
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Concomitant participation of the patient in another research involving the human person
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | CHU d'Angers | Angers | France | 49933 | |
2 | CHU de Dijon | Dijon | France | 21079 | |
3 | CHU de Montpellier | Montpellier | France | 34295 | |
4 | CHU de Nice | Nice | France | 06202 |
Sponsors and Collaborators
- University Hospital, Montpellier
- Guerbet
Investigators
- Principal Investigator: Boris GUIU, Montpellier University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RECHMPL17_0304
- 2017-004859-22
- UF 9888