The Asia-Pacific Hepatocellular Carcinoma Trials Group (AHCC) protocol 06 SIRveNIB randomised controlled study of SIR-Spheres Y-90 resin microspheres versus sorafenib in the treatment of unresectable primary liver cancer (hepatocellular carcinoma or HCC) has completed its target enrolment of at least 360 patients.
SIRveNIB was designed to compare the efficacy and safety of selective internal radiation therapy (SIRT) with yttrium-90 (Y-90) resin microspheres (SIR-Spheres, Sirtex Medical) versus sorafenib (Nexavar, Bayer HealthCare Pharmaceuticals). The patients in SIRveNIB were ineligible for potentially curative therapies, such as surgical resection, ablation or liver transplantation.
Pierce Chow, principal investigator of the SIRveNIB study, and senior consultant surgeon at the National Cancer Centre Singapore and the Singapore General Hospital, explains that, “The search for more effective and better tolerated treatments of HCC is important, as so few proven treatment options currently exist. Beyond the primary endpoint of overall survival in SIRveNIB, we are also looking at a number of important secondary endpoints, including a comparison of the side effects and patient quality of life, with these two very different approaches to treating unresectable HCC. SIRveNIB is the largest Asia-Pacific study to directly compare SIRT and sorafenib, and indeed is the largest randomised study conducted on sorafenib in the region.”
“Completion of patient enrolment in the investigator-led SIRveNIB study represents a milestone in Asian liver cancer research, and underscores the strong private-public partnership that exists between Sirtex Medical, the National Cancer Centre Singapore and Singapore Clinical Research Institute”, says associate professor Teoh Yee Leong, chief executive officer, Singapore Clinical Research Institute.
SIRveNIB patients were treated at 27 centres across 10 Asia-Pacific countries including New Zealand.
The results of SIRveNIB are expected to become available in the first half of 2017.