The Impact on Hepatic Recurrence After Adjuvant Chemotherapy With Intraarterial Infusion of Idarubicin-Lipiodol (LIDA-ADJ)

University Hospital Center (CHU)

Status and phase

Withdrawn

Phase 2

Conditions

Hepatocellular Carcinoma

Treatments

Drug: percutaneous destruction of the tumor + Idarubicin-Lipiodol treatment

Procedure: Percutaneous destruction of the tumor

Study type

Interventional

Funder types

Other

Identifiers

NCT04178642

7773 (Other Identifier)

2019-001362-15 (EudraCT Number)

RECHMPL19_0073

Details and patient eligibility

About

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.

Full description

During this study percutaneous tumor destruction treatment with adjuvant chemotherapy (infusion of Idarubicin-Lipiodol intra-arterial hepatic) will be tested. The adjuvant chemotherapy is a minimally invasive technique. It consists of the administration of Idarubicin (Zavedos®, Pfizer) mixed with Lipiodol (Lipiodol Ultra-Fluid®, Guerbet) in the hepatic artery.The first course of treatment will be performed under general anesthesia at the same time as the percutaneous tumour ablation. The second and third cures will be performed under local anesthesia 3 and 6 weeks after percutaneous tumour ablation respectively. In the case of incomplete treatment during the percutaneous tumour ablation, the second intervention will be scheduled at the same time as the second intra-arterial chemotherapy treatment, under general anesthesia.

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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