Radioembolisation (TARE) with durvalumab in hepatocellular carcinoma

A phase I/IIa pilot trial (Aliseda et al., Clinical Cancer Research 2023) treated 24 patients with locally advanced, unresectable hepatocellular carcinoma (Child-Pugh score up to 7, BCLC stage B or non-metastatic BCLC-C) with yttrium-90 radioembolisation followed 7-14 days later by intravenous durvalumab 1500 mg every 4 weeks. At a median follow-up of 19 months, median time to progression was 15.2 months, 18-month overall survival was 58.3%, and the objective response rate by modified RECIST was 83.3% (29.2% complete response, 54.2% partial response). Toxicity was modest: 47.8% of patients had any-grade treatment-related adverse events and only 8.7% had grade 3 events (neutropenia, fever), with no treatment-related serious adverse events.

This single-arm signal has prompted larger prospective studies of TARE plus durvalumab-based regimens, including the phase II ROWAN study (NCT05063565, Boston Scientific-sponsored, TheraSphere followed by durvalumab plus a single dose of tremelimumab, the STRIDE regimen; enrolment of 100 patients completed August 2025, results expected 2027) and EMERALD-Y90 (NCT06040099, AstraZeneca-sponsored, TARE followed by durvalumab and bevacizumab, 58 patients enrolled). A retrospective National Cancer Database analysis of 1,664 patients cited by Boston Scientific also associated TARE plus immunotherapy with improved survival compared with immunotherapy alone, though retrospective comparisons of this kind cannot rule out selection bias.

As of September 2026 none of the randomised, adequately powered trials of TARE plus systemic immunotherapy in HCC has reported a definitive survival readout; the evidence base is early-phase and registry-level. Clinicians should treat the high response rates from the pilot study as hypothesis-generating rather than practice-changing pending ROWAN and EMERALD-Y90 results.