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>.

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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
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article

BioPearl™ doxorubicin microspheres for unresectable HCC: a prospective, single-arm, multicenter study: BIOPEARL-ONE

Irene Bargellini, Philippe L. Pereira, Gontran Verset, Roberto Iezzi et al.
2 citations
Future Oncology
Hepatocellular Carcinoma Treatment and Prognosis
0.74
article

BioPearl™ doxorubicin microspheres for unresectable HCC: a prospective, single-arm, multicenter study: BIOPEARL-ONE

Irene Bargellini, Philippe L. Pereira, Gontran Verset, Roberto Iezzi, Carlo Spreafico, Ana‐Maria Bucalau, Gerd Grözinger, Geert Maleux
article en
2 citations

Abstract

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>.

Future OncologyVol. 21(5)
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)
Zero hunger
Openalex Percentile: Top 26%
Hepatocellular Carcinoma Treatment and Prognosis
0.74
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