Comparing microwave ablation treatments for liver cancer

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

This study is testing three different ways to treat liver cancer in patients with specific tumor sizes to see which method works best for getting rid of the cancer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Pisa (Academic / other)
• Drugs / interventions: doxorubicin
• Locations: 1 site (Pisa)
• Trial ID: NCT05592171 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and efficacy of three different treatment approaches for patients with hepatocellular carcinoma (HCC) nodules measuring 3-5 cm. Participants will be randomly assigned to one of three groups: microwave ablation combined with drug-eluting bead transarterial chemoembolization (DEB-TACE), microwave ablation alone, or microwave ablation with DEB-TACE without the Occlusafe® balloon. The primary goal is to assess the effectiveness of these treatments one month post-procedure, focusing on complete tumor ablation, while secondary objectives include monitoring the time to local disease recurrence. This study seeks to address the lack of a preferred interventional treatment for HCC nodules of this size in non-surgical patients.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a single HCC nodule sized 3-5 cm who are not candidates for liver resection.

Not a fit: Patients with extrahepatic metastasis, portal or hepatic vein invasion, or those who have previously received treatment for HCC may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients with HCC, potentially improving tumor control and patient outcomes.

How similar studies have performed: While similar approaches have been explored, this specific combination of treatments with the Occlusafe® balloon is novel and has not been extensively tested in prior studies.

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.

Where this trial is running

Pisa

• Azienda Ospedaliero-Universitaria Pisana — Pisa, Italy (Recruiting)

Study contacts

• Principal investigator: Laura Crocetti, MD, PhD — University of Pisa
• Study coordinator: Laura Crocetti, MD, PhD

Conditions HCC