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SIRveNIB


The SIRveNIB Study

The SIRveNIB study was a phase III multi‐centre open‐label randomised controlled study which compared the efficacy and safety of SIRT with SIR-Spheres® Y-90 resin microspheres versus sorafenib in locally advanced hepatocellular carcinoma (HCC).

The SIRveNIB study was an investigator-initiated study conducted by The Asia-Pacific Hepatocellular Carcinoma Trials Group (AHCC) in collaboration with the National Cancer Centre Singapore and Singapore Clinical Research Institute (SCRI) and supported by the National Medical Council Singapore and Sirtex Medical Limited.

The patients in SIRveNIB were ineligible for potentially curative therapies, such as surgical resection, ablation or liver transplantation.

SIRveNIB Key Findings

The SIRveNIB Study showed, that compared with sorafenib, local treatment of advanced or inoperable Hepatocellular Carcinoma (HCC) with SIR-Spheres Y-90 resin microspheres:

  • did not show a significant improvement in overall survival
  • had a significantly reduced frequency and severity of adverse events
  • was significantly better tolerated
  • significantly improved PFS and TTP, overall and in the liver, in the treated population

Chow PKH et al. J Clin Oncol 2018; 36: 1913-1921.

 




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Effective May 7, 2021, SIR-Spheres will have the following indication for use:
SIR-Spheres Y-90 resin microspheres are indicated for the treatment of unresectable hepatocellular carcinoma (HCC) and unresectable metastatic liver tumors from primary colorectal cancer in patients refractory to or intolerant of chemotherapy.

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