Sirtex Microspheres to Be Studied for Cholangiocarcinoma in SIRCCA and Included in ESMO Guidelines
October 11, 2016—Sirtex Medical Ltd announced the commencement of SIRCCA (Selective Internal Radiation Therapy [SIRT] in Cholangiocarcinoma), a phase 2 study of the company’s SIR-Spheres yttrium-90 (Y-90) resin microspheres in patients with unresectable intrahepatic cholangiocarcinoma (iCCA).
According to Sirtex, SIRCCA is a prospective multicenter randomized controlled clinical study evaluating SIRT with the company’s microspheres before cisplatin-gemcitabine (CIS-GEM) chemotherapy versus CIS-GEM chemotherapy alone—the current standard of care—as a first-line treatment of patients with unresectable iCCA.
The study is expected to enroll 180 patients at 30 centers across Australia and Europe, with the first patient recruited before the end of 2016. Recruitment is anticipated to be completed in late 2018. The primary endpoint of the study is overall survival at 18 months. Key secondary endpoints include progression-free survival (PFS) in the liver, PFS at any site, overall survival, objective response rate, liver surgical resection and ablation rate, and safety and tolerability.
Sirtex also advised that the European Society of Medical Oncology (ESMO) highlighted the role of Y-90 microspheres for the treatment of iCCA with the publication of clinical practice guidelines on biliary cancers. The guidelines were published by Prof. Juan W. Valle, MD, et al as a supplement to the Annals of Oncology (2016;27[suppl 5]:v28–v37).
Treatment with SIR-Spheres Y-90 resin microspheres is cited as an important postchemotherapy option for patients with locally advanced or metastatic iCCA. For these patients, there is no current standard of care beyond first-line treatment with cisplatin and gemcitabine chemotherapy, noted Sirtex.
Prof. Valle, Lead Author of the guidelines, stated that radioembolization via SIRT, “...may be considered in patients with inoperable iCCA, usually after first-line chemotherapy.” Prof. Valle is from the department of medical oncology at Christie NHS Foundation Trust, University of Manchester, in Manchester, United Kingdom.