Evaluation of the efficacy and tolerance of a chemotherapy by Idarubicin and Lipiodol emulsion administer in the liver, by the hepatic artery, on hepatocellular carcinoma.

Phase 1

Conditions: The research hypothesis is that hepatic locoregional treatment without embolization, using a more cytotoxic anticancer molecule (Idarubicin) than those conventionally used, would be more effective.
MedDRA version: 20.0Level: LLTClassification code 10019828Term: Hepatocellular carcinoma non-resectableSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2017-004859-22-FR

Lead Sponsor: niversity Hospital of Monptellier

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 53

Inclusion Criteria

• Histologically proven hepatocellular carcinoma (or according to EASL criteria)
• Child-Pugh A or B7 cirrhosis
• Tumor not accessible to surgical resection, percutaneous ablation or radiofrequency
• WHO 0 or 1
• BCLC A / B or C if WHO = 1
• Targets measurable according to mRECIST criteria v1.1
• No previous treatment with chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy) or radioembolisation
• Age = 18 years
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Advanced tumor disease
• Diffuse hepatocellular carcinoma with liver invasion> 50%
• Past cancers history excluding cancers known to have been cured for more than 5 years, or basocellular skin tumors or cervical cancer in situ adequately treated with curative intent
• Advanced liver disease (Child B8, B9 and C)
• Contraindication to performing a liver MRI
• Contraindication to the injection of gadolinium-based contrast media
• Contraindication to Idarubicin
• Contraindication to Lipiodol
• Vascular anatomy makes it impossible to perform intra-arterial liver treatments
• Ligation or sizing of gastroesophageal varices for less than a month.
• Pregnancy (determination of positive ßHCG) or breastfeeding according to article L1121-5 of the CSP.