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Evaluating the efficacy of an adjuvant treatment by hepatic arterial chemo-infusion of Idarubicin-Lipiodol (experimental group)

The absence of adjuvant treatment (standard group).

Patients will receive the standard treatment protocol consisting of a percutaneous destruction of the tumor. In addition they will receive an adjuvant treatment by hepatic arterial chemo-infusion of Idarubicin (Zavedos®, Pfizer), which is an anthracycline antineoplastic agent, mixed with Lipiodol (Lipiodol Ultra-Fluid®, Guerbet), which is a contrast agent.

percutaneous destruction of the tumor + Idarubicin-Lipiodol treatment

Patients will received the standard treatment protocol consisting of a percutaneous destruction of the tumor.

Percutaneous destruction of the tumor

Christophe CASSINOTTO

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.

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.

Prospective multi-center phase II, randomized, unmasked comparative study (ratio 1:1), evaluating the efficacy of an adjuvant treatment by hepatic arterial chemo-infusion of Idarubicin-Lipiodol (experimental group) after percutaneous tumor ablation of hepatocellular carcinoma of size less than 3 cm, versus the absence of adjuvant treatment (standard group), on hepatic recurrence at 1 year.

It is planned to include 138 patients with hepatocellular carcinoma (CHC) less than 3 cm, non-metastatic, with cirrhosis graded A / B7 on Child Pugh scoring system, and receiving treatment by percutaneous tumor destruction.

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

Hepatocellular Carcinoma Under 3 cm Treated by Percutaneous Tumor Destruction: Multicentric Phase 2 Test Evaluating the Impact of Adjuvant Chemotherapy by Intra-arterial Infusion of Idarubicin-lipiodol on the Hepatic Recurrence

Hepatic recurrence will be defined as the appearance on at least one hepatic MRI with gadolinium injection of a large diameter tumor site at least greater than 10 mm, and presenting characteristics of CHC (hyper vascularization at arterial time and washing at portal or late time), either at the edge of the percutaneous tumor destruction site (= local recurrence) or at a distance from the percutaneous tumor destruction site (= intrahepatic recurrence distant), or both, after at least one liver MRI scan with gadolinium injection showed the absence of tumor residues. Lesions of more than 10 mm that do not present with the typical CHC enhancement described above will be considered CHCs if they have a growth in size of at least 1 cm on successive controls.

The incidence rate of local tumor recurrence at 1 and 2 years, defined as the appearance, on at least one hepatic MRI with gadolinium injection, of a tumor site with hepatocellular carcinoma characteristics at the edge of the percutaneous tumor ablation site.

The incidence rate of intrahepatic recurrence at 1 and 2 years defined as the appearance, on at least one hepatic MRI with gadolinium injection, of a tumor site with hepatocellular carcinoma characteristics at a distance from the percutaneous tumor ablation site.

The incidence rate of hepatic recurrence at 2 years defined as the appearance, on at least one hepatic MRI with gadolinium injection, of a tumor site with hepatocellular carcinoma, after at least one exploration by hepatic MRI with gadolinium injection, showed the absence of tumor residue.

Survival without hepatic recurrence defined as the time between the date of randomization and the date of liver MRI, having confirmed, after centralized and blind re-examination, the presence of a hepatic tumor recurrence either local or intra distant hepatic. Patients who are deceased or transplanted will be considered to have liver progression at the time of death or transplantation.

Rate of survival without hepatic recurrence at 1 and 2 years defined as the absence of appearance of a large diameter tumor site (at least greater than 10 mm), presenting characteristics of hepatocellular carcinoma on the border of the percutaneous tumour ablation site.

Overall survival defined as the time between the date of randomization and the date of death of the patient.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
The Impact on Hepatic Recurrence After Adjuvant Chemotherapy With Intraarterial Infusion of Idarubicin-Lipiodol	NCT04178642	Hepatocellular ...	percutaneous de... Percutaneous de...	18 Years - 80 Years	University Hospital, Montpellier
The Impact on Hepatic Recurrence After Adjuvant Chemotherapy With Intraarterial Infusion of Idarubicin-Lipiodol	NCT04178642	Hepatocellular ...	percutaneous de... Percutaneous de...	18 Years - 80 Years	University Hospital, Montpellier

Spots Global Cancer Trial Database for percutaneous destruction of the tumor