NRT is delighted to announce the oral presentation of data of Phase I/II First-in-Human Trial of Yttrium-90 Carbon Microspheres in Patients with Unresectable Hepatocellular Carcinoma (uHCC), which demonstrated encouraging preliminary efficacy and a manageable safety profile.
The 16th Asia-Pacific Primary Liver Cancer Expert Meeting (APPLE) was held in Shanghai, July 3-5, bringing together more than 500 participants and over 90 renowned experts from around the globe.
Selected as the only clinical study on Y-90 TARE for an oral presentation at the conference, the study results were presented by Professor Hai-Dong Zhu from Zhongda Hospital, Southeast University, China.
The study is a prospective, multicenter, open-label, single-arm trial (NCT06310590), designed to evaluate the safety and efficacy of Yttrium-90 Carbon Microspheres in patients with uHCC. Primary endpoints include incidences of adverse events (AEs) and serious adverse events (SAEs), and localized objective response rate (ORR) per mRECIST in the initial treated area. A total of 40 patients with uHCC from eight centers in China were enrolled.
Key Findings:
• The best overall ORR and best localized ORR were 92.5% and 95.0%, respectively.
• The confirmed overall ORR and localized ORR were 75.0% and 77.5%, respectively.
• Six patients initially determined unresectable were successfully converted and subsequently underwent surgical resection.
• Safety data also demonstrated favorable profile.
The pivotal multicenter randomized controlled Phase III clinical trial (NCT06900543) of NRT6003 for the treatment of patients with uHCC has successfully completed patient enrollment. Clinical studies evaluating the potential of Yttrium-90 Carbon Microspheres in pancreatic cancer are also progressing steadily.
