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

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.

Study Overview

• Status: Recruiting
• Conditions: HCC
• Intervention / Treatment: Procedure: Microwave ablation + Occlusafe + DEB-TACE; Procedure: Microwave ablation + Occlusafe; Procedure: Microwave ablation + DEB-TACE

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura Crocetti, MD, PhD; Phone Number: +39 050995551; Email: laura.crocetti@unipi.it
• Study Contact Backup: Name: Beatrice Silvestrini; Email: beatrice.silvestrini@med.unipi.it

Study Locations

• Italy
  • Pisa, Italy, 56126
    • Recruiting
    • Azienda Ospedaliero-Universitaria Pisana
    • Contact: Laura Crocetti, MD, PhD; Phone Number: +39 050995551; Email: laura.crocetti@unipi.it
    • Contact: Beatrice Silvestrini; Email: beatrice.silvestrini@med.unipi.it
    • Principal Investigator: Laura Crocetti, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Occlusafe assisted MWA+ DEB-TACE	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.
Other: Occlusafe assisted MWA	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.
Other: MWA+ DEB-TACE	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to local disease recurrence	● Relapse-free survival analysis. Appearance of local disease recurrence on CT examination with contrast medium performed according to the scheduled timing	1 month, 4 months, 7 months, 10 months, 13 months

Collaborators and Investigators

• Sponsor: University of Pisa
• Collaborators: Azienda Ospedaliera Città della Salute e della Scienza di Torino; Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Azienda Ospedaliera Universitaria Policlinico; IRCCS Azienda Ospedaliero-Universitaria di Bologna; Terumo Europe N.V.; Azienda Ospedaliero, Universitaria Pisana
• Investigators: Principal Investigator: Laura Crocetti, MD, PhD, University of Pisa

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2022
• Primary Completion (Anticipated): November 1, 2024
• Study Completion (Anticipated): October 17, 2025

Study Registration Dates

• First Submitted: October 17, 2022
• First Submitted That Met QC Criteria: October 21, 2022
• First Posted (Actual): October 24, 2022

Study Record Updates

• Last Update Posted (Actual): October 24, 2022
• Last Update Submitted That Met QC Criteria: October 21, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Antineoplastic Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Estrogens, Non-Steroidal; Estrogens; Chlorotrianisene
• Other Study ID Numbers: 21704

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No