hepatocellular carcinoma MedDRA version: 20.0 Level: LLT Classification code 10049010 Term: Carcinoma hepatocellular System Organ Class: 100000004864
Conditions
Interventions
Trade Name: ADRIBLASTINE 50mg, poudre solution injectable en flacon
Pharmaceutical Form: Powder for solution for injection
Pharmaceutical Form: Solution for injection
INN or Proposed INN: FLUORESCEIN
Sponsors
Hôpitaux Universitaires de Strasbourg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - man and womanof 18 years old or older - Subject affiliated to social security - Subject able to understand study scope and rick and give signed informed consent - histological, cytological or radiological confirmed diagnosis of Hepatocellular carcinoma: ? stade A (patient with transplant pending) and Class B according to BCLC Classification ? Sated A and Baccording to Child-Pugh classification - chemoembolization indicated for unresecable hepatocellular carcinoma - biological parmaters allowing chemoembolization procedure (platelet count, bilirubin, INR = 1,5, SGPT/SGOT2,5g/dl) - ECOG performance status = 2 - effective contracpetion during all study - negative prenancy test for woman child-bearing Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 14 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 14
Exclusion criteria
Exclusion criteria: - Any contra-indication for the procedure of transarterial Chemoembolization, angiography, endomicroscopie, and hepatic biopsy ponction - blood coagulation parameters abnormalities (TP 40 µmol/L - Créatinin > 2mg/dl - GFR < 30ml/min/m2 - Neutrophiles < 1500/mm3 ou Plaquettes < 50000/µl - Hémoglobin < 9g/dl - white cells < 2500/mm3 - full or flux invesion of portal vein thrombosis - extrahepatic metastasis - transplant list inscription - exophytic or sub capsilaire tumor, with no percutaneous access accross healthy liver with coaxial needle - exclusion period - subject unable to understand study information - Psychiatric disorders and adults under guardianship - Pregnancy or breastfeeding - Patients under judicial protection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: intratumoral doxorubicin kinetic distribution assessment with histological analysis as part of lipiodol transarterial chemoembolization, depend on used reconstitution solvent (NaCL 0.9% VS Visipaque);Secondary Objective: 1. Assessment of solvent influence used to Doxorubicine dissolution on intratumoral doxorubicin distribution kinetic with Confocal Lazer Endomicroscopy (CLE) 2. Safety evaluation;Primary end point(s): Histological analysis : - distribution, frequence, fluorescence intensity frome tumor and adjacent non tumoral hepatic tissu - tissular slide doxorubicin quantification : flourescence produce by tissular compartment and surface;Timepoint(s) of evaluation of this end point: at the end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): n° 1 : Confocal lazer endomicroscopie : - time of emulsion arrival - time of drug delivery - time of droplet fusion n° 2 : collection of study adverse event and serious adverse event;Timepoint(s) of evaluation of this end point: n° 1 : during chemoembolization procédure n°2 : during all the study | — |
Countries
France
Contacts
Public ContactDirection de la Recherche Clinique
Hôpitaux Universitaires de Strasbourg
Outcome results
None listed