NCT05592171

Occlusafe® Assisted MW Alone or With DEB-TACE Compared to MW With DEB-TACE in the Treatment of HCC

A Randomized, Controlled, Open-label Study of the Safety and Efficacy of Occlusafe® Assisted Microwave Alone or in Combination With DEB-TACE Compared to Microwave in Combination With DEB-TACE in the Treatment of Intermediate Size HCC

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Pisa · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this Interventional Study is to compare the efficacy profile and safety of three treatments in patients with HCC nodule. Patients will be randomly divided in three arms: 1. Occlusafe assisted MWA+ DEB-TACE 2. Occlusafe assisted MWA 3. MWA+ DEB-TACE The primary objectives are evaluate the safety of the three treatments; evaluate the effectiveness of treatments one month after the procedure (defined as complete ablation of macroscopic tumor at one month of follow-up), verifying the possible superiority of arm 1 and arm 2 compared to arm 3. The secondary objective is: time to local disease recurrence.

Detailed description

Microwave ablation (MW) is based on the production of heating by friction given by the oscillation of water molecules. The delivery of drug-releasing microspheres (DEB-TACE) at the same time as microwave ablation, could promote the arrest of tumor growth. After positioning and inflating the Occlusafe® balloon in the artery that connects to the HCC nodule, the blood flow tends to go preferentially to the HCC nodule compared to the healthy liver. In addition, the flow is slowed down inside the nodule due to the drop in the resistance of the tumor arteries, resulting in stagnation of intranodular blood. The increase in the water content in the tumor area, after using the Occlusafe® balloon microcatheter, could increase the ability of microwave ablation to cover larger volumes in a shorter time. In parallel, the delivery of drug-releasing microspheres (DEB-TACE) is provided both with inflation with Occlusafe® and without. This will allow to verify if a better treatment efficiency can be achieved in the peripheral ablation areas. The study also includes a third control arm, consisting of ablation and DEB-TACE without Occlusafe®. There is currently no interventional radiological treatment in the European guidelines to be preferred for HCC nodules 3-5cm in size in non-surgical patients. Since these procedures are used in clinical practice, but the guidelines do not indicate a gold standard for non-surgical loco-regional treatment of HCC larger than 3 cm, the study aims to compare the efficacy profile and safety of the three treatments.

Conditions

• HCC

Interventions

Type	Name	Description
PROCEDURE	Microwave ablation + Occlusafe + DEB-TACE	Microwave ablation (MW) is based on the production of heating by friction given by the oscillation of water molecules. After positioning and inflating the Occlusafe® balloon in the artery that connects to the HCC nodule, the blood flow tends to go preferentially to the HCC nodule compared to the healthy liver. The increase in the water content in the tumor area, after using the Occlusafe® balloon microcatheter, could increase the ability of microwave ablation to cover larger volumes in a shorter time. The delivery of drug-releasing microspheres (DEB-TACE) at the same time as microwave ablation, could promote the arrest of tumor growth.
PROCEDURE	Microwave ablation + Occlusafe	Microwave ablation (MW) is based on the production of heating by friction given by the oscillation of water molecules. After positioning and inflating the Occlusafe® balloon in the artery that connects to the HCC nodule, the blood flow tends to go preferentially to the HCC nodule compared to the healthy liver. The increase in the water content in the tumor area, after using the Occlusafe® balloon microcatheter, could increase the ability of microwave ablation to cover larger volumes in a shorter time.
PROCEDURE	Microwave ablation + DEB-TACE	Microwave ablation (MW) is based on the production of heating by friction given by the oscillation of water molecules. The delivery of drug-releasing microspheres (DEB-TACE) at the same time as microwave ablation, could promote the arrest of tumor growth.

Timeline

• Start date: 2022-10-17
• Primary completion: 2024-11-01
• Completion: 2025-10-17
• First posted: 2022-10-24
• Last updated: 2022-10-24

Locations

1 site across 1 country: Italy