Internal view of patient's torso demonstrating targeted accuracy of TheraSphere Y-90 Glass Microspheres in liver.

TheraSphere™ CLINICAL EVIDENCE

PROACTIF study HCC data

PROACTIF: The largest, prospective, real-world Y-90 study with TheraSphereTM for the treatment of liver malignancies

Full HCC Analysis
 

connected people
989 HCC
Hospital
34 Sites
All-comers (2019 – 2024)
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PROACTIF Study, demonstrates favorable effectiveness and safety of TheraSphereTM Y-90 Therapy in the real-world clinical complexity of HCC. 

The data demonstrate meaningful survival across BCLC stages—even in a predominantly intermediate and advanced population (77%)—including patients with large tumours, also patients with PVT, with outcomes driven by personalised dosimetry.  Higher absorbed doses and downstaging to surgery were associated with strong survival—more than doubling median overall survival in patients who underwent surgery.

With preserved liver function and the ability to maintain treatment options, PROACTIF reinforces the role of personalised TheraSphereTM Y-90 Therapy as a key component of multidisciplinary, multimodal HCC care pathways.

Meaningful Survival in Complex HCC

Median OS across BCLC
B: 27.0 mo | C: 21.1 mo

Vp1/Vp2 survival comparable to no PVT
24.8 vs. 23.1 mo (HR 0.99)

Dose drives survival, particularly in large tumours (> 5 cm)
36.4 vs. 18.5 mo (≥400 Gy vs. <400 Gy)

Enabled Curative-Intent Surgery and Preserved Options

Downstaging to surgery more than doubled overall survival
48.6 vs. 20.1 mo (no surgery)

Favorable safety profile preserved eligibility for subsequent treatment
53.7% received subsequent therapy
3.7% with treatment-related SAEs

Supports Use of Personalised Y-90 across HCC Care

Personalised dosimetry with TheraSphereTM Y-90 is reproducible at a large scale across centers

PROACTIF reinforces role of Y-90 patient selection and treatment technique, and importance of repeated MDT assessment of surgical eligibility


Guiu et al. Effectiveness and Safety of Selective Internal Radiation Therapy using Yttrium-90 Glass Microspheres for Hepatocellular Carcinoma: Real-world Results from the Multi-center Prospective PROACTIF Cohort of 989 Patients. eClinicalMedicine. Published Online https://doi.org/10.1016/j.eclinm.2026.103884

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