Study of BioPearl Microspheres with Doxorubicin for Treating Unresectable Liver Cancer Hepatocellular Carcinoma Single-Arm, Multi-Center Clinical Follow-Up

What this Trial Is About

Researchers are evaluating the safety and effectiveness of BioPearl21 microspheres loaded with Doxorubicin in treating adults with unresectable hepatocellular carcinoma HCC, a type of liver cancer that cannot be removed by surgery. This prospective, single-group study aims primarily to confirm the safety and technical success of this treatment, while also investigating its ability to control tumor growth and improve survival. The study involves 50 participants and includes an intermediate safety analysis to meet regulatory requirements. Participants will receive Transarterial Chemo Embolization TACE using BioPearl21 microspheres loaded with Doxorubicin. This procedure delivers the treatment directly to the liver tumors. The study follows patients through treatment until their disease progresses or they require another treatment option. Afterward, participants will be monitored for survival, with follow-up lasting up to 18 months. Throughout the study, participants will have clinical evaluations to assess safety by monitoring serious adverse events related to the procedure or device, as well as technical success shortly after treatment. Tumor response, progression-free survival, time to progression, duration and best response, and overall survival will be measured over 18 months. Participants will be monitored regularly to track these outcomes and their health status, ensuring comprehensive follow-up for up to 18 months after treatment begins.

BioPearl™ Microspheres Loaded With Doxorubicin for the Treatment of Unresectable Hepatocellular Carcinoma (HCC)