NCT04178642

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	percutaneous destruction of the tumor + Idarubicin-Lipiodol treatment	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.
PROCEDURE	Percutaneous destruction of the tumor	Patients will received the standard treatment protocol consisting of a percutaneous destruction of the tumor.

Timeline

• Start date: 2020-09-22
• Primary completion: 2021-07-14
• Completion: 2021-07-14
• First posted: 2019-11-26
• Last updated: 2022-12-14

Locations

1 site across 1 country: France