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

NCT ID: NCT05592171

Last Updated: 2022-10-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-17
• Study Completion Date: 2025-10-17

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Occlusafe assisted MWA+ DEB-TACE

Group Type: OTHER

Microwave ablation + Occlusafe + DEB-TACE

Intervention Type: PROCEDURE

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.

Occlusafe assisted MWA

Group Type: OTHER

Microwave ablation + Occlusafe

Intervention Type: PROCEDURE

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.

MWA+ DEB-TACE

Group Type: OTHER

Microwave ablation + DEB-TACE

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Male or female ≥ 18 years of age;
• any ethnicity;
• Patient with almost one HCC 3-5cm with biopsy according to EASL/EORTC guidelines;
• Patient is not candidate for liver resection;
• Child Pugh A;
• Eastern Cooperative Oncology Group (ECOG) performance status 0;
• Willing to sign an informed consent form, indicating awareness of the investigational nature of this study that is in keeping with the policies of the institution.

Exclusion Criteria

• Have previously received therapeutic treatment for HCC outside the study protocol;
• Have extrahepatic metastasis;
• Have portal or hepatic vein tumor invasion/thrombosis;
• Baseline laboratories:

Platelet count < 50,000/mm3; INR > 1,5;

• Baseline Chemistry: Serum creatinine ≥ 2.0 mg/dL or calculated creatinine clearance (CrCl) ≤30.0 mL/min; Serum bilirubin > 3.0 mg/dL;

• Are pregnant or breast-feeding. In women of childbearing potential, a negative serum pregnancy test is required prior to study treatment;
• Have contraindications to receiving doxorubicin;
• Have other concurrent malignancy (subjects with treated squamous cell carcinoma of the skin or basal cell carcinoma of the skin may be included), evidence of extrahepatic cancer from their primary malignancy, or ongoing, medically significant active infection.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: collaborator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: collaborator

Azienda Ospedaliera Universitaria Policlinico

OTHER

Sponsor Role: collaborator

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: collaborator

Terumo Europe N.V.

INDUSTRY

Sponsor Role: collaborator

Azienda Ospedaliero, Universitaria Pisana

OTHER

Sponsor Role: collaborator

University of Pisa

OTHER

Sponsor Role: lead

Responsible Party

Laura Crocetti

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laura Crocetti, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pisa

Locations

Azienda Ospedaliero-Universitaria Pisana

Pisa, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Laura Crocetti, MD, PhD

Role: CONTACT

laura.crocetti@unipi.it

+39 050995551

Beatrice Silvestrini

Role: CONTACT

beatrice.silvestrini@med.unipi.it

Facility Contacts

Laura Crocetti, MD, PhD

Role: primary

laura.crocetti@unipi.it

+39 050995551

Beatrice Silvestrini

Role: backup

beatrice.silvestrini@med.unipi.it

Other Identifiers

21704

Identifier Type: -

Identifier Source: org_study_id