Status:
UNKNOWN
Occlusafe® Assisted MW Alone or With DEB-TACE Compared to MW With DEB-TACE in the Treatment of HCC
Lead Sponsor:
University of Pisa
Collaborating Sponsors:
A.O.U. Città della Salute e della Scienza
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
HCC
Eligibility:
All Genders
18+ years
Phase:
NA
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 ass...
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 micro...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 17 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05592171
Start Date
October 17 2022
End Date
October 17 2025
Last Update
October 24 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Azienda Ospedaliero-Universitaria Pisana
Pisa, Italy, 56126