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

NCT05592171 | Unknown

• 1 other identifier: 21704
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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. 1.Occlusafe assisted MWA+ DEB-TACE
2. 2.Occlusafe assisted MWA
3. 3.MWA+ DEB-TACE

Conditions

HCC

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Treatment-Related Adverse Events as Assessed by CIRSE classification of complications

  Evaluate the safety of the three treatments by CIRSE classification

  immediately after the procedure

• Number of Participants With Treatment-Related Adverse Events as Assessed by CIRSE classification of complications

  Evaluate the safety of the three treatments by CIRSE classification

  30 days

• Number of participants with complete response according to mRECIST one month after the procedure

  Number of participants with complete response according to mRECIST one month after the procedure, verifying the possible superiority of arm 1 and arm 2 compared to arm 3.

  one month

Secondary Outcomes (1)

• Time to local disease recurrence

  1 month, 4 months, 7 months, 10 months, 13 months

Study Arms (3)

Occlusafe assisted MWA+ DEB-TACE

OTHER

Procedure: Microwave ablation + Occlusafe + DEB-TACE

Occlusafe assisted MWA

OTHER

Procedure: Microwave ablation + Occlusafe

MWA+ DEB-TACE

OTHER

Procedure: Microwave ablation + DEB-TACE

Interventions

Microwave ablation + Occlusafe + DEB-TACE 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+ DEB-TACE

Microwave ablation + Occlusafe 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.

Occlusafe assisted MWA

Microwave ablation + DEB-TACE 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.

MWA+ DEB-TACE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pisa: lead
• A.O.U. Città della Salute e della Scienza: collaborator
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: collaborator
• Azienda Ospedaliera Universitaria Policlinico: collaborator
• IRCCS Azienda Ospedaliero-Universitaria di Bologna: collaborator
• Terumo Europe N.V.: collaborator
• Azienda Ospedaliero, Universitaria Pisana: collaborator

Study Sites (1)

Azienda Ospedaliero-Universitaria Pisana

Pisa, 56126, Italy

RECRUITING

Study Officials

• Laura Crocetti, MD, PhD

  University of Pisa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Crocetti, MD, PhD

CONTACT

+39 050995551; laura.crocetti@unipi.it

Beatrice Silvestrini

CONTACT

beatrice.silvestrini@med.unipi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized open-label interventional study on a medical device.

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: October 24, 2022
• Study Start: October 17, 2022
• Primary Completion: November 1, 2024
• Study Completion: October 17, 2025
• Last Updated: October 24, 2022

Record last verified: 2022-10

Locations

IT (1)