BioPearl™ doxorubicin microspheres for unresectable HCC: a prospective, single-arm, multicenter study: BIOPEARL-ONE
Drug-eluting microsphere transarterial chemoembolization (DEM-TACE) reduces systemic exposure to chemotherapeutic drugs compared with conventional TACE but permanently occludes the embolized vessels, potentially obviating the possibility of re-treatment with TACE. Temporary embolization by resorbable BioPearl™ microspheres might facilitate subsequent re-treatments. We herein describe the trial protocol of BIOPEARL-ONE, a prospective, single-arm, multicenter, post-market clinical follow-up study. The primary objectives are technical success and safety following the use. DEM-TACE with doxorubicin-loaded BioPearl™ for unresectable hepatocellular carcinoma (HCC). The secondary objectives are tumor response, duration of response, progression-free survival, and survival rate at 18 months. Fifty patients with HCC nodules smaller than 5 cm and within the up-to-7 criteria will be enrolled.<b>Clinical Trial Registration: NCT05911633</b>.
Authors
- Irene Bargellini (ORCID: https://orcid.org/0000-0002-5641-1330)
- Philippe L. Pereira (ORCID: https://orcid.org/0000-0002-9913-2120)
- Gontran Verset (ORCID: https://orcid.org/0000-0003-1912-6327)
- Roberto Iezzi (ORCID: https://orcid.org/0000-0002-2791-481X)
- Carlo Spreafico (ORCID: https://orcid.org/0000-0002-8505-108X)
- Ana‐Maria Bucalau (ORCID: https://orcid.org/0000-0003-0444-7806)
- Gerd Grözinger (ORCID: https://orcid.org/0000-0002-0102-187X)
- Geert Maleux (ORCID: https://orcid.org/0000-0003-0598-0258)
Institutions
- Agostino Gemelli University Polyclinic (IT)
- Advanced Radiation Therapy (United States) (US)
- Società Italiana di Cardiologia Interventistica (IT)
- Institut Paoli-Calmettes (FR)
- Candiolo Cancer Institute (IT)
- Istituti di Ricovero e Cura a Carattere Scientifico (IT)
- SLK-Kliniken Heilbronn (DE)
- Fondazione IRCCS Istituto Nazionale dei Tumori (IT)
- University of Tübingen (DE)
- KU Leuven (BE)
Publication Details
- Journal
- Future Oncology
- Published
- 2024-12-30
- DOI
- https://doi.org/10.1080/14796694.2024.2446137
- Citations
- 2
- Primary Topic
- Hepatocellular Carcinoma Treatment and Prognosis
- Type
- article
- Field-Weighted Citation Impact
- 0.74