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

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Recruiting
CT.gov ID
NCT03727633
Collaborator
Guerbet (Industry)
53
4
1
69.4
13.3
0.2

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
  • Drug: Idarubicin and Lipiodol
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
53 participants
Allocation:
N/A
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.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 :
Jul 19, 2018
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. Objective response rate of chemo-lipiodol [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 [6 months]

    The best response according to mRECIST at 6 months after the first cycle of chemo-lipiodol

  4. Overall survival [12 months]

    Overall survival at 12 months after the first cycle of chemo-lipiodol

  5. 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

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 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

Contacts and Locations

Locations

Site City State Country Postal Code
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.
Responsible Party:
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT03727633
Other Study ID Numbers:
  • RECHMPL17_0304
  • 2017-004859-22
  • UF 9888
First Posted:
Nov 1, 2018
Last Update Posted:
Dec 28, 2021
Last Verified:
Dec 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 28, 2021