Terumo Launches Study for Resorbable Microsphere Efficacy in Liver Cancer Treatment

Terumo Europe has initiated a study to evaluate the safety and efficacy of BioPearl microspheres, designed for treating unresectable hepatocellular carcinoma (HCC) with doxorubicin. This multi-centre post-market clinical trial involves six European centres aiming to generate evidence on the potential benefits of these microspheres in TACE (transarterial chemoembolization) procedures, offering a new approach to improve treatment outcomes and follow-up options for HCC patients.

TACE is the guideline-recommended, first line treatment of patients with intermediate-stage HCC 1–6 and DEM-TACE provides a standardized treatment approach 1,2,7. However, with well-established TACE techniques, signs of liver injury and hepatic insufficiency are the most common adverse effects8 while liver function must be preserved to safely perform potential follow up surgery, systemic or intra-arterial locoregional treatments9.

BioPearl Microspheres are the first resorbable drug-eluting microspheres designed to allow progressive blood flow restoration and lesion intra-arterial access, offering more opportunities for future treatments *10-11. BioPearl microspheres bring the confidence of the embolic effect and sustained drug release from the drug-loadable Microspheres technology11.

In the BIOPEARL-ONE study, patients will be enrolled in six European centers with the aim of generating post-market clinical evidence on the potential benefits of resorbable drug-eluting microspheres.

Prof Roberto Iezzi from Fondazione Policlinico Gemelli IRCCS, Catholic University, in Rome, coordinating investigator, said: “BioPearl Microspheres and its degradation profile brings a new concept to the TACE therapy and will hopefully allow for improved follow-up treatment outcomes thanks to the expected vessel flow restoration. BIOPEARL-ONE study will give us greater insights on this new technology's clinical outcomes."

Ghada Farah, Senior Vice President TIS EMEA, said: “I'm really excited about the launch of the BIOPEARL-ONE study. It is a major milestone to make BioPearl Microspheres, Terumo's latest innovation in TACE treatment, available to TACE eligible patients – enabling healthcare providers to open new horizons in treating HCC."

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