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SIRveNIB hepatocellular carcinoma study completes enrollment
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The Asia-Pacific Hepatocellular Carcinoma Trials Group, National Cancer Centre Singapore, Singapore Clinical Research Institute and Sirtex Medical Limited announced that the AHCC protocol 06 SIRveNIB randomized controlled study of SIR-Spheres Y-90 microspheres vs. sorafenib for the treatment of hepatocellular carcinoma has reached target enrollment of at least 360 patients.
The study, created to compare the use of selective internal radiation therapy (SIRT) with yttrium-90 resin microspheres (SIR-Spheres, Sirtex Medical Limited) vs. sorafenib (Nexavar, Bayer HealthCare Pharmaceuticals), sought to involve patients who were ineligible for other potentially curable therapies. Patients were then treated at 27 centers across 10 Asia-Pacific countries, including New Zealand.
“The search for more effective and better tolerated treatments of HCC is important, as so few proven treatment options currently exist,” Professor Pierce Chow, MBBS, investigator on the SIRveNIB study and senior consultant surgeon at the National Cancer Centre Singapore, said in a press release.
Currently, sorafenib is the standard treatment for patients with advanced hepatocellular carcinoma. However, 80% of patients receiving sorafenib also experienced treatment-related adverse effects, according to the press release. SIRT with SIR-Spheres Y-90 resin microspheres treat inoperable liver tumors by delivering high-energy radiation via the tumors’ own blood supply. Radioactive microspheres are administered through a catheter into liver arteries that supply the tumors with blood, delivering short-range radiation up to 40 times higher than conventional radiotherapy, according to the release.
SIR-Spheres Y-90 resin microspheres have pre-market approval from the FDA and, in combination with intra-hepatic artery chemotherapy using floxuride, are indicated in the United States for the treatment of nonresectable metastatic liver tumors from primary colorectal cancer.
The results of the SIRveNIB study are expected in the first half of 2017.
Disclosure: The study is sponsored by Singapore General Hospital in collaboration with National Medical Research Council, Singapore, National Cancer Centre Singapore and the Singapore Clinical Research Institute as well as Sirtex Medical Limited.