Overview
The Impact on Hepatic Recurrence After Adjuvant Chemotherapy With Intraarterial Infusion of Idarubicin-Lipiodol
Status:
Recruiting
Recruiting
Trial end date:
2026-01-22
2026-01-22
Target enrollment:
0
0
Participant gender:
All
All
Summary
The aim of this study is to test whether the realization of 3 courses of intra-arterial chemotherapy of idarubicin-lipiodol without embolization, administered non-selectively in the hepatic artery, following the percutaneous tumour ablation of a hepatocellular carcinoma, could constitute an effective adjuvant treatment to reduce the rates of local and intrahepatic distant recurrence and thus improve the survival without hepatic progression.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
University Hospital, MontpellierTreatments:
Ethiodized Oil
Idarubicin
Criteria
Inclusion Criteria:- Age above 18 and under 80 years-old
- Chronic or histologically proven stage F3 or F4 hepatopathy, with liver hardness ≥ 10
kPa, or with imaging morphology suggestive of cirrhosis or portal hypertension
- Child-Pugh score ≤ B7
- Patients whose biological parameters meet the following criteria:
- Platelets > 50,000 / mm3
- Neutrophils > 1000 / mm3
- Prothrombin ratio > 50%
- Creatinemia < 150 μmol / L
- Total bilirubinemia < 5 mg / dL
- α-fetoprotein < 200 ng / mL
- Performance level of 0 or 1 according to "World Health Organization Performance
Status"
- Presence of a single hepatocellular carcinoma of less than 3 cm with typical imaging
characteristics as recommended by the American Association for the Study of Liver
Diseases (AASLD)
- Patient with an indication of percutaneous tumor ablation (radiofrequency or
microwave) under ultrasound or tomodensitometric identification
- Absence of heart failure (Left Ventricular Ejection Fraction (LVEF) > 50%)
- Women of childbearing age, using an effective method of contraception for the duration
of treatment and at least 3 months after stopping the treatment.
- Male using an effective method of contraception throughout the treatment and at least
3 months after stopping the treatment
Exclusion Criteria:
- Presence on the initial imaging assessment of a macroscopic vascular invasion (portal
or hepatic vein)
- Presence on initial imaging assessment of extrahepatic localization of hepatocellular
carcinoma
- Presence of another untreated cancer
- Patients who previsouly received sphincterotomy or bilio-digestive anastomosis
- Contraindication to performing a general anesthesia
- Contraindication to performing an MRI scan
- Allergy to anthracyclines, iodine or gadolinium
- Contraindication to the injection of gadolinium-based contrast media.
- Contraindication to iodinated contrast agents
- Contraindication to Idarubicin (hypersensitivity to the active substance or
excipients, severe heart disease, severe arrhythmia, severe renal or hepatic
impairment, yellow fever vaccine or any other live attenuated vaccine for 6 months
after discontinuation of chemotherapy, persistent myelosupressure, previous treatments
with idarubicin and / or other anthracyclines or anthracenediones at maximum
cumulative doses, mucositis, breastfeeding, uncontrolled infections, severe heart
failure, myocardial infarction less than 6 months old).
- Contraindication to Lipiodol (Hypersensitivity, Hyperthyroidism, traumatic lesions,
haemorrhage or recent bleeding)
- Patients who have already received or exceeded the recommended cumulative dose for
anthracyclines (Idarubicin = 150 mg / m²)
- Patients who cannot temporarily stop their anticoagulant treatment or anti-platelet
agent for the duration of the procedure
- Failure of endoscopic eradication of oesophageal varices of grade > 1
- Inability to adhere to the protocol
- Simultaneous participation to another clinical trial
- Patients not covered by health insurance