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

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Tác giả: Irene Bargellini, Ana-Maria Bucalau, Gerd Groezinger, Roberto Iezzi, Geert Maleux, Philippe Pereira, Carlo Spreafico, Gontran Verset

Ngôn ngữ: eng

Ký hiệu phân loại: 641.5611 Cooking

Thông tin xuất bản: England : Future oncology (London, England) , 2025

Mô tả vật lý:

Bộ sưu tập: NCBI

ID: 469628

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.
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