The Impact on Hepatic Recurrence After Adjuvant Chemotherapy With Intraarterial Infusion of Idarubicin-Lipiodol

• Status: Recruiting
• Trial end date: 2026-01-22
• Target enrollment: 0
• Participant gender: 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 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Montpellier
• Treatments: 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