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

Launched by UNIVERSITY OF PISA · Oct 21, 2022

Keywords

ClinConnect Summary

This clinical trial is studying different treatment options for patients with hepatocellular carcinoma (HCC), a type of liver cancer. Researchers want to see how effective and safe three treatment methods are: one that combines a technique called Occlusafe-assisted microwave ablation (MWA) with a procedure known as DEB-TACE, another that uses Occlusafe-assisted MWA alone, and a third that combines MWA with DEB-TACE without Occlusafe. The main goal is to find out which treatment works best in completely eliminating the tumor one month after the procedure and to monitor how quickly the cancer may return.

To participate, you must be at least 18 years old, have one tumor in your liver that is between 3 to 5 centimeters, and not be a candidate for surgery. You also need to be in relatively good health, with no significant liver damage or other serious health issues. If you join the trial, you will be randomly assigned to one of the three treatment groups. Throughout the study, your safety and the effectiveness of the treatment will be closely monitored. This trial is currently recruiting participants, and it's important to note that those who are pregnant or have certain other health conditions may not be eligible.

Gender

ALL

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.