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

NCT03727633 | Terminated Phase 2

• 3 other identifiers: RECHMPL17_03042017-004859-22UF 9888
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 4

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.

Conditions

Carcinoma, Hepatocellular

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Safety of chemo-lipiodol defined by NCI-CTCAE version 4.03

  12 months

• Objective response rate of chemo-lipiodol

  6 months

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

  6 months

• Overall survival

  12 months

• Quality of life questionnaire (QLQ) QLQ-C30

  12 months

Study Arms (1)

Treatment arm

EXPERIMENTAL

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

Drug: Idarubicin and Lipiodol

Interventions

Idarubicin and Lipiodol DRUG

Hepatic intra-arterial chemotherapy consisting of the hepatic intra-arterial injection Idarubicin, emulsified with Lipiodol

Treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Guerbet: collaborator

Study Sites (4)

CHU d'Angers

Angers, 49933, France

Location

CHU de Dijon

Dijon, 21079, France

Location

CHU de Montpellier

Montpellier, 34295, France

Location

CHU de Nice

Nice, 06202, France

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Idarubicin; Ethiodized Oil

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Iodized Oil; Plant Oils; Oils; Lipids; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Boris GUIU

  Montpellier University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: No masking is used. All involved know the identity of the intervention assignment.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 31, 2018
• First Posted: November 1, 2018
• Study Start: July 19, 2018
• Primary Completion: June 18, 2025
• Study Completion: January 3, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

FR (4)