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Enrollment complete for SORAMIC study for primary HCC

Enrollment for the Pan-European SORAMIC clinical trial, a study that will investigate the safety and efficacy of Nexavar combined with SIR-Spheres for the treatment of primary hepatocellular carcinoma, is now complete, according to a press release.

The SORAMIC study is the first large randomized trial to compare the efficacy of a combination regimen of Nexavar (sorafenib, Bayer, Germany) and selective internal radiation therapy (SIRT) with SIR-Spheres (Y-90 resin microspheres, Sirtex Medical Limited, Australia) vs. sorafenib alone in unresectable primary HCC.

“For the past 10 years, sorafenib has been the sole standard of care for treating patients with advanced HCC, or any HCC that has spread beyond the liver,” Jens Ricke, MD, director of the Clinic for Radiology and Nuclear Medicine at the University of Magdeburg, Germany, and investigator of the study, said in the release. “We hope that the results of this large [trial] will demonstrate that the combination of sorafenib and Y-90 resin microspheres may provide a new treatment standard for patients with HCC who are not eligible for surgical resection or ablation.”

Jens Ricke

The study consists of two parts: the diagnostic part, where contrast-enhanced MRI and computed tomography (CT) will be compared to determine if MRI is comparable to CT for identification of HCC lesions, and the therapeutic part which will involve randomization of 420 patients to treatment with sorafenib plus Y-90 microspheres or sorafenib alone, according to the release.

Results of the SORAMIC study are expected to be available in 2018.

Disclosure: Healio.com/Hepatology was unable to confirm relevant financial disclosures of Ricke at the time of publication.