Overview of Yttrium-90 radioembolization for advanced hepatocellular carcinoma: Current status and future perspectives

Table 1 Landmark trials

Trial	Design	Intervention	Primary endpoint	Key findings	Clinical implications
SARAH	Phase III, open-label, randomized controlled trial	Yttrium-90 resin microspheres (radioembolization) vs sorafenib	OS	Median OS: Radioembolization 8.0 months vs sorafenib 99 months; no significant difference. Radioembolization group experienced fewer adverse events and better quality of life	Radioembolization offers comparable survival to sorafenib with improved tolerability, suggesting it as an alternative for certain patients[11]
SIRveNIB	Phase III, open-label, randomized controlled trial	Yttrium-90 resin microspheres (radioembolization) vs sorafenib	OS	Median OS: Radioembolization 8.8 months vs sorafenib 100 months; no significant difference. Radioembolization group had significantly fewer grade ≥ 3 adverse events (27.7% vs 50.6%)	Confirms radioembolization's comparable efficacy and better safety profile, supporting its use in selected patient populations[12]
DOSISPHERE-01	Phase II, open-label, randomized controlled trial	Personalized dosimetry radioembolization vs standard dosimetry radioembolization	OS	Median OS: Personalized dosimetry 26.6 months vs standard dosimetry 10.7 months (P = 0.0096). Higher tumor response rates and potential for downstaging to surgery in the personalized group	Personalized dosimetry significantly improves outcomes, advocating for individualized treatment planning in radioembolization[13]

OS: Overall survival.