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Hepatocellular Carcinoma on Cirrhosis With Child A/B7 and Hepatic Intra Arterial Injection of Idarubicin/Lipiodol Emulsion (LIDA-BII)

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ClinicalTrials.gov Identifier: NCT03727633
Recruitment Status : Recruiting
First Posted : November 1, 2018
Last Update Posted : November 22, 2018
Sponsor:
Collaborator:
Guerbet
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Carcinoma, Hepatocellular Drug: Idarubicin and Lipiodol Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 53 participants
Intervention Model: Single Group Assignment
Intervention Model Description: The purpose of this study is to assess efficacy and tolerance of hepatic intra-arterial injection of an emulsion of Idarubicine and Lipiodol for treatment of non-metastatic, unresectable hepatocellular carcinoma on cirrhosis with Child-Pugh A/B7.
Masking: None (Open Label)
Masking Description: No masking is used. All involved know the identity of the intervention assignment.
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : June 26, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2021


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Percentage of participants presenting a disease control at 4 months [ Time Frame: 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 :
  1. Safety of chemo-lipiodol defined by NCI-CTCAE version 4.03 [ Time Frame: 12 months ]
    Safety defined by NCI-CTCAE version 4.03 published 14 june 2010

  2. Objective response rate of chemo-lipiodol [ Time Frame: 6 months ]
    Objective response rate according to mRECIST at 6 months after the first cycle

  3. best response at 6 months after the first cycle of chemo-lipiodol according to mRECIST [ Time Frame: 6 months ]
    The best response according to mRECIST at 6 months after the first cycle of chemo-lipiodol

  4. Overall survival [ Time Frame: 12 months ]
    Overall survival at 12 months after the first cycle of chemo-lipiodol

  5. Quality of life questionnaire (QLQ) QLQ-C30 [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 excluding cancers known to have been cured for more than 5 years (in this case, histological evidence of HCC is required), 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03727633


Contacts
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Contact: Boris GUIU, MD 04 67 33 75 46 b-guiu@chu-montpellier.fr

Locations
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France
CHU d'Angers Not yet recruiting
Angers, France, 49933
Contact: Christophe AUBE, PH         
CHU de Dijon Not yet recruiting
Dijon, France, 21079
Contact: Romaric LOFFROY, PH         
CHU de Montpellier Recruiting
Montpellier, France, 34295
Contact: Boris GUIU, PUPH         
CHU de Nice Not yet recruiting
Nice, France, 06202
Contact: Patrick CHEVALLIER, PH         
Sponsors and Collaborators
University Hospital, Montpellier
Guerbet

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03727633     History of Changes
Other Study ID Numbers: UF 9888
2017-004859-22 ( EudraCT Number )
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: November 22, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Idarubicin
Ethiodized Oil
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action