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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

Tracking Information
First Submitted Date  ICMJE May 31, 2018
First Posted Date  ICMJE November 1, 2018
Last Update Posted Date November 22, 2018
Actual Study Start Date  ICMJE June 26, 2018
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03727633 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2018)
  • 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
  • Objective response rate of chemo-lipiodol [ Time Frame: 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 [ Time Frame: 6 months ]
    The best response according to mRECIST at 6 months after the first cycle of chemo-lipiodol
  • Overall survival [ Time Frame: 12 months ]
    Overall survival at 12 months after the first cycle of chemo-lipiodol
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2018)
  • 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
  • Objective response rate of chemo-lipiodol [ Time Frame: 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 [ Time Frame: 6 months ]
    The best response according to mRECIST at 6 months after the first cycle of chemo-lipiodol
  • Overall survival [ Time Frame: 12 months ]
    Overall survival at 12 months after the first cycle of chemo-lipiodol
  • Quality of life QLQ-C30 questionnaire [ Time Frame: 12 months ]
    Quality of life at 12 months after the first cycle of chemo-lipiodol (QLQ-C30 questionnaire)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hepatocellular Carcinoma on Cirrhosis With Child A/B7 and Hepatic Intra Arterial Injection of Idarubicin/Lipiodol Emulsion
Official Title  ICMJE 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.
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Carcinoma, Hepatocellular
Intervention  ICMJE Drug: Idarubicin and Lipiodol
Hepatic intra-arterial chemotherapy consisting of the hepatic intra-arterial injection Idarubicin, emulsified with Lipiodol
Study Arms  ICMJE Experimental: Treatment arm
hepatic intra-arterial injection of an emulsion of Idarubicine and Lipiodol
Intervention: Drug: Idarubicin and Lipiodol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 31, 2018)
53
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Boris GUIU, MD 04 67 33 75 46 b-guiu@chu-montpellier.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03727633
Other Study ID Numbers  ICMJE UF 9888
2017-004859-22 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Montpellier
Study Sponsor  ICMJE University Hospital, Montpellier
Collaborators  ICMJE Guerbet
Investigators  ICMJE Not Provided
PRS Account University Hospital, Montpellier
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP