PROACTIF study overview
The largest, prospective, real-world, Y-90 study of primary liver cancer in 1,000+ patients using TheraSphere Y-90 Glass Microspheres.
See Protocol Publication and CT.gov listing
1,000+ patients
First multi-center, 1,000+ patient study that builds on previously published TheraSphere landmark trials which span the Barcelona Clinic Liver Cancer (BCLC) guidelines
30+ sites
Data from 30+ sites using contemporary techniques and dosing
Study objective
The study aims to gather data on effectiveness, patient quality of life (QoL), and safety with use of TheraSphere Y-90 glass microspheres in real-world clinical settings in France.
Primary endpoints
Overall survival (OS) from time of TheraSphere treatment and quality of life, as assessed by using the functional assessment of Cancer Therapy – Hepatobiliary (FACT-Hep) questionnaire.
Key secondary endpoints
Grade ≥3 AEs, SAEs, tumor response, tumor marker response, subsequent therapy, and dosimetry evaluations.
AE = Adverse event. SAE = Serious adverse event.
This study is sponsored by Boston Scientific. Final results are expected in 2025 and will include full patient population with additional information on quality of life, safety and dosimetry.
Garin E, Bailly C, Letang A et al. Abstract No. 257 • Featured Abstract The PROACTIF French Registry Study of Y-90 Glass Microspheres for the Treatment of Liver Malignancies: Interim Analysis of 670 Hepatocellular Carcinoma (HCC) Patients. J Vasc Interv Radiol. 2024 Mar 35(3):S113 doi: https://doi.org/10.1016/j.jvir.2023.12.295 (updated dataset for oral presentation at SIR March 2024)
TheraSphere is a registered trademark of Theragenics Corporation used under license by Boston Scientific Medical Device Limited, a wholly owned indirect subsidiary of Boston Scientific Corporation.
Results from different clinical investigations are not directly comparable. Information provided for educational purposes only.
Caution:
The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings, and instructions for use can be found in the product labelling supplied with each device or at www.IFU-BSCI.com. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. This material not intended for use in France.