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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Hepatic intra-arterial chemotherapy consisting of the hepatic intra-arterial injection Idarubicin, emulsified with Lipiodol
CHU d'Angers
Angers, France
CHU de Dijon
Dijon, France
CHU de Montpellier
Montpellier, France
CHU de Nice
Nice, France
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.
Time frame: 4 months
Safety of chemo-lipiodol defined by NCI-CTCAE version 4.03
Safety defined by NCI-CTCAE version 4.03 published 14 june 2010
Time frame: 12 months
Objective response rate of chemo-lipiodol
Objective response rate according to mRECIST at 6 months after the first cycle
Time frame: 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
Time frame: 6 months
Overall survival
Overall survival at 12 months after the first cycle of chemo-lipiodol
Time frame: 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.
Time frame: 12 months
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