Pre-transplant downstaging strategies for hepatocellular carcinoma with portal vein tumor thrombus: Current therapies and future challenges

Table 3 Key clinical trials evaluating selective internal radiation therapy (transarterial radioembolization) for hepatocellular carcinoma

Trial	Phase/design	Comparison	Primary endpoint	Results	Clinical insights
SARAH	Phase III, open-label, randomized controlled trial	SIRT (Y-90) vs Sorafenib	Overall survival (OS)	OS: 8.0 months (SIRT) vs 9.9 months (Sorafenib)- no significant difference. Fewer AEs and better QoL in SIRT group	Comparable efficacy with better safety; viable alternative in select patients
SIRveNIB	Phase III, open-label, randomized controlled trial	SIRT (Y-90) vs Sorafenib	OS	OS: 8.8 months (SIRT) vs 10.0 months (Sorafenib) no significant difference. Grade ≥ 3 AEs: 27.7% (SIRT) vs 50.6% (Sorafenib)	Reinforces safety advantage of SIRT; supports use in selected Asian patient populations
DOSISPHERE-01	Phase II, open-label, randomized controlled trial	Personalized SIRT vs Standard-dose SIRT	OS	OS: 26.6 months (personalized) vs 10.7 months (standard) P = 0.009. Higher response rates; some downstaged to surgery	Personalized dosimetry improves outcomes; highlights need for tailored treatment planning

AE: Adverse events; QoL: Quality of life; SIRT: Selective internal radiation therapy.