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

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.

Conditions

• HCC

Interventions

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.

Sponsors & Collaborators

• A.O.U. Città della Salute e della Scienza

  collaborator OTHER

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  collaborator OTHER

• Azienda Ospedaliera Universitaria Policlinico

  collaborator OTHER

• IRCCS Azienda Ospedaliero-Universitaria di Bologna

  collaborator OTHER

• Terumo Europe N.V.

  collaborator INDUSTRY

• Azienda Ospedaliero, Universitaria Pisana

  collaborator OTHER

• University of Pisa

  lead OTHER

Principal Investigators

• Laura Crocetti, MD, PhD · University of Pisa

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-10-17

Primary Completion

2024-11-30

Completion

2025-10-17

Countries

• Italy

Study Locations