The SORAMIC Study
SORAMIC is the first large randomised controlled trial (RCT) to compare the efficacy and safety of combining sorafenib and SIR-Spheres® Y-90 resin microspheres versus sorafenib alone in the treatment of HCC in the palliative cohort. Patients with HCC who took part in the palliative cohort of the SORAMIC study were not eligible for resection or ablation and were not ideal candidates for transarterial chemoembolisation (TACE).
The primary endpoint of the palliative arm of the SORAMIC study was Overall Survival (OS). Secondary endpoints included Safety and OS for patients with and without portal vein thrombosis.
SORAMIC Key Findings
Patients with locally advanced HCC treated with SIR-Spheres Y-90 resin microspheres in combination with sorafenib:
- showed no significant improvement in Overall Survival compared to sorafenib alone
- had a similar safety and toxicity profile as patients treated with sorafenib alone
Specific patient sub-groups seem to benefit from the addition of SIR-Spheres Y-90 resin microspheres to sorafenib
- <65 years
- non-cirrhotic patients
- non-alcoholic etiology
Ricke J et al. J Hepatol 2019; 71: 1164-1174.