Clinical trial NCT03727633: Hepatocellular Carcinoma on Cirrhosis With Child A/B7 and Hepatic Intra Arterial Injection of Idarubicin/Lipiodol Emulsion
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
Overall status: RECRUITING
Phase: PHASE2
Conditions: Carcinoma, Hepatocellular
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Guerbet
First posted: 2018-11-01
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of participants presenting a disease control at 4 months
timeFrame: 4 months
Secondary outcomes:
measure: Safety of chemo-lipiodol defined by NCI-CTCAE version 4.03
timeFrame: 12 months
measure: Objective response rate of chemo-lipiodol
timeFrame: 6 months
measure: best response at 6 months after the first cycle of chemo-lipiodol according to mRECIST
timeFrame: 6 months
measure: Overall survival
timeFrame: 12 months
measure: Quality of life questionnaire (QLQ) QLQ-C30
timeFrame: 12 months
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU d'Angers
city: Dijon
country: France
facility: CHU de Dijon
city: Montpellier
country: France
facility: CHU de Montpellier
city: Nice
country: France
facility: CHU de Nice
Study officials:
affiliation: Montpellier University Hospital
name: Boris GUIU
role: PRINCIPAL_INVESTIGATOR
References: