6/29/23, 11:57 PM STORM Pathway Feedback Search Clinical Topics Home Studies STORM STORM Disease Hepatocellular carcinoma Trial question What is the role of adjuvant sorafenib in patients with HCC following resection or ablation? Study design Multi-center Double blinded RCT Population Characteristics of study participants 18.0% female N = 1114 82.0% male 1114 patients (202 female, 912 male) Inclusion criteria: patients with HCC with a complete radiological response after surgical resection or local ablation Key exclusion criteria: recurrent HCC; macrovascular invasion; CVD; infection with human immunodeficiency virus or other clinically serious infections; seizure disorder requiring drugs; previous anticancer treatment for HCC Interventions N=556 sorafenib (at an oral dose of 400 mg BID, for a maximum of 4 years) N=558 placebo (matching placebo BID, for a maximum of 4 years) Primary outcome https://web.pathway.md/studies/rec5NOqYclIxQWr4H 1/2 6/29/23, 11:57 PM STORM Pathway Median recurrence-free survival 33.7 months 33.7 33.3 25.3 months 16.9 months 8.4 months No significant difference 0.0 months Sorafenib Placebo No significant difference in median recurrence-free survival (33.3 months vs. 33.7 months; HR 0.94, 95% CI 0.78 to 1.13) Secondary outcomes No significant difference in median time to recurrence (38.5 months vs. 35.8 months; HR 0.891, 95% CI 0.73 to 1.08) Safety outcomes No significant difference in any adverse event. Significant differences in drug-related adverse events (94% vs. 46%), grade 3 or 4 hand-foot skin reaction (28% vs. <1%). Conclusion In patients with HCC with a complete radiological response after surgical resection or local ablation, sorafenib was not superior to placebo with respect to median recurrence-free survival. Reference Jordi Bruix, Tadatoshi Takayama, Vincenzo Mazzaferro et al. Adjuvant sorafenib for hepatocellular carcinoma after resection or ablation (STORM): a phase 3, randomised, double-blind, placebo- controlled trial. Lancet Oncol. 2015 Oct;16(13):1344-54. Open reference URL https://web.pathway.md/studies/rec5NOqYclIxQWr4H 2/2