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SIR 2026

Scientific Session

Interventional Oncology

Abstract of the Year

Session: Abstracts of the Year and Late-breaking Abstracts Presentations

3 - Y90 Glass Microsphere Treatment for Intrahepatic Cholangiocarcinoma: Final Results from the Largest Prospective Real-World Study (PROACTIF)

Monday, April 13, 2026
10:18 AM - 10:27 AM ET
Purpose: This study evaluated the effectiveness, safety, and dosimetry of TARE with yttrium-90 (Y90) glass microspheres in a real-world clinical setting. Herein, we present the final data for patients with intrahepatic cholangiocarcinoma (iCCA).

Materials and Methods: All patients treated with Y90 glass microspheres (TheraSphere™) across 34 French institutions who were not opposed to data collection were included and followed prospectively during a 4 year period. Duration of follow-up and overall survival (OS) were assessed by reverse Kaplan-Meier (KM) and KM analysis, respectively. Toxicity was assessed using CTCAE v5 grading for adverse events (AEs).

Results: A total of 207 patients were included, 56.5% were ECOG 0; 31.9% had associated liver fibrosis or cirrhosis; 52.7% had a solitary lesion, median index lesion size was 7.0 cm (interquartile range, 5.0 – 9.5) according to RECIST 1.1. and central read. Patients were either treatment naïve (n=108; 52.2%) or had prior treatment (n= 77; 37.2%, systemic, n=70; locoregional, n=7; surgery, n=10). Concomitant systemic treatment was provided for 70 patients (33.8%) mostly Gemcitabine-cisplatin combination. 56.5% of patients received post progression subsequent treatment including surgery (n=27). 68.1% of patients had multicompartment dosimetry and 58.9% had selective treatment administration. Median follow-up was 31.0 months. Median OS (mOS) [95% CI] was 21.9 months (M) [18.2 – 24.3]. By subgroup mOS was 24.2M for patients with a single tumor versus 17.2M for patients with multiple tumors; 23.3M without cirrhosis/fibrosis versus 19.8M with cirrhosis/fibrosis; 21.3M without concomitant systemic treatment versus 21.9M with concomitant treatment, 23.3M in naïve patients versus 11.4M in recurrent disease. Patients with subsequent surgery had the greatest survival benefit (mOS not reached) compared to patients with subsequent treatment excluding surgery (n=90), patients with no subsequent treatment (n=76), and patients with unknown or missing data (n=14): 21.3M, 17.4M, and 12.7M, respectively. In total 19 AEs Grade≥3 and 18 serious AEs were reported.

Conclusion: This real-world study demonstrates and confirms that Y90 treatment is a key option in patients with iCCA with an acceptable safety profile and meaningful survival including patient with cirrhosis and allowing 13% of subsequent resection or transplantation.