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

Area of Science:

• Interventional Radiology
• Oncology
• Hepatobiliary Medicine

Background:

• Conventional transarterial chemoembolization (TACE) using drug-eluting microspheres (DEM-TACE) reduces systemic drug exposure but causes permanent vessel occlusion, hindering re-treatment.
• Resorbable microspheres offer a potential solution for temporary embolization, preserving vessel patency for subsequent interventions.

Purpose of the Study:

• To evaluate the technical success and safety of DEM-TACE with doxorubicin-loaded BioPearl™ in patients with unresectable hepatocellular carcinoma (HCC).
• To assess secondary endpoints including tumor response, duration of response, progression-free survival, and overall survival at 18 months.

Main Methods:

• The BIOPEARL-ONE study is a prospective, single-arm, multicenter, post-market clinical follow-up trial.
• Fifty patients with unresectable HCC (nodules <5 cm, within up-to-7 criteria) will be enrolled.
• The intervention involves DEM-TACE using doxorubicin-loaded, resorbable BioPearl™ microspheres.

Main Results:

• Primary objectives focus on technical success and safety of the DEM-TACE procedure.
• Secondary objectives include evaluating tumor response, duration of response, progression-free survival, and survival rates.

Conclusions:

• The study protocol aims to establish the feasibility and safety of using resorbable microspheres in DEM-TACE for HCC.
• Successful outcomes could support the use of this technique for repeated treatments in HCC management.