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

Carcinoma, Hepatocellular Clinical Trial

— 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03727633
• Other study ID #: RECHMPL17_0304
• Secondary ID: 2017-004859-22UF
• Status: Recruiting
• Phase: Phase 2
• Start date: July 19, 2018
• Est. completion date: January 18, 2026

Study information

• Verified date: January 2024
• Source: University Hospital, Montpellier
• Contact: Boris GUIU, MD
• Phone: 04 67 33 75 46
• Email: b-guiu[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 53
• Est. completion date: January 18, 2026
• Est. primary completion date: December 18, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Drug:
• Idarubicin and Lipiodol
Hepatic intra-arterial chemotherapy consisting of the hepatic intra-arterial injection Idarubicin, emulsified with Lipiodol

Locations

Country	Name	City	State
France	CHU d'Angers	Angers
France	CHU de Dijon	Dijon
France	CHU de Montpellier	Montpellier
France	CHU de Nice	Nice

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Guerbet

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Objective response rate of chemo-lipiodol	Objective response rate according to mRECIST at 6 months after the first cycle	6 months
Secondary	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
Secondary	Overall survival	Overall survival at 12 months after the first cycle of chemo-lipiodol	12 months
Secondary	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