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

Primary Purpose

Carcinoma, Hepatocellular

Status
Recruiting
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Idarubicin and Lipiodol
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Hepatocellular

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU d'AngersRecruiting
  • CHU de Dijon
  • CHU de MontpellierRecruiting
  • CHU de NiceRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment arm

Arm Description

hepatic intra-arterial injection of an emulsion of Idarubicine and Lipiodol

Outcomes

Primary Outcome Measures

Percentage of participants presenting a disease control at 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
Safety defined by NCI-CTCAE version 4.03 published 14 june 2010
Objective response rate of chemo-lipiodol
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
The best response according to mRECIST at 6 months after the first cycle of chemo-lipiodol
Overall survival
Overall survival at 12 months after the first cycle of chemo-lipiodol
Quality of life questionnaire (QLQ) QLQ-C30
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.

Full Information

First Posted
May 31, 2018
Last Updated
May 2, 2023
Sponsor
University Hospital, Montpellier
Collaborators
Guerbet
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1. Study Identification

Unique Protocol Identification Number
NCT03727633
Brief Title
Hepatocellular Carcinoma on Cirrhosis With Child A/B7 and Hepatic Intra Arterial Injection of Idarubicin/Lipiodol Emulsion
Acronym
LIDA-BII
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 19, 2018 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
Guerbet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Hepatocellular

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
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.
Allocation
N/A
Enrollment
53 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment arm
Arm Type
Experimental
Arm Description
hepatic intra-arterial injection of an emulsion of Idarubicine and Lipiodol
Intervention Type
Drug
Intervention Name(s)
Idarubicin and Lipiodol
Intervention Description
Hepatic intra-arterial chemotherapy consisting of the hepatic intra-arterial injection Idarubicin, emulsified with Lipiodol
Primary Outcome Measure Information:
Title
Percentage of participants presenting a disease control at 4 months
Description
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.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Safety of chemo-lipiodol defined by NCI-CTCAE version 4.03
Description
Safety defined by NCI-CTCAE version 4.03 published 14 june 2010
Time Frame
12 months
Title
Objective response rate of chemo-lipiodol
Description
Objective response rate according to mRECIST at 6 months after the first cycle
Time Frame
6 months
Title
best response at 6 months after the first cycle of chemo-lipiodol according to mRECIST
Description
The best response according to mRECIST at 6 months after the first cycle of chemo-lipiodol
Time Frame
6 months
Title
Overall survival
Description
Overall survival at 12 months after the first cycle of chemo-lipiodol
Time Frame
12 months
Title
Quality of life questionnaire (QLQ) QLQ-C30
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Boris GUIU, MD
Phone
04 67 33 75 46
Email
b-guiu@chu-montpellier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boris GUIU
Organizational Affiliation
Montpellier University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU d'Angers
City
Angers
ZIP/Postal Code
49933
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe AUBE, PH
Facility Name
CHU de Dijon
City
Dijon
ZIP/Postal Code
21079
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Romaric LOFFROY, PH
Facility Name
CHU de Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boris GUIU, PUPH
Facility Name
CHU de Nice
City
Nice
ZIP/Postal Code
06202
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick CHEVALLIER, PH

12. IPD Sharing Statement

Learn more about this trial

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

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