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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Carcinoma, Hepatocellular
• Intervention / Treatment: Drug: Idarubicin and Lipiodol

• Study Type: Interventional
• Enrollment (Estimated): 53
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Boris GUIU, MD; Phone Number: 04 67 33 75 46; Email: b-guiu@chu-montpellier.fr

Study Locations

• France
  • Angers, France, 49933
    • Recruiting
    • CHU d'Angers
    • Contact: Christophe AUBE, PH
  • Dijon, France, 21079
    • Not yet recruiting
    • CHU de Dijon
    • Contact: Romaric LOFFROY, PH
  • Montpellier, France, 34295
    • Recruiting
    • CHU de Montpellier
    • Contact: Boris GUIU, PUPH
  • Nice, France, 06202
    • Recruiting
    • CHU de Nice
    • Contact: Patrick CHEVALLIER, PH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of chemo-lipiodol defined by NCI-CTCAE version 4.03	Safety defined by NCI-CTCAE version 4.03 published 14 june 2010	12 months
Objective response rate of chemo-lipiodol	Objective response rate according to mRECIST at 6 months after the first cycle	6 months
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	6 months
Overall survival	Overall survival at 12 months after the first cycle of chemo-lipiodol	12 months
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.	12 months

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: Guerbet
• Investigators: Principal Investigator: Boris GUIU, Montpellier University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2018
• Primary Completion (Estimated): December 18, 2024
• Study Completion (Estimated): January 18, 2026

Study Registration Dates

• First Submitted: May 31, 2018
• First Submitted That Met QC Criteria: October 31, 2018
• First Posted (Actual): November 1, 2018

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 15, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Idarubicin; Ethiodized Oil
• Other Study ID Numbers: RECHMPL17_0304; 2017-004859-22 (EudraCT Number); UF 9888 (Other Identifier: Montpellier University Hospital)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No