Table 4. Summary of Ongoing and Recruiting Clinical Trials for Y90-SIRT for HCC Treatment (6).
| Clinical Trials.gov Identifier | Treatment Arm(s) | Patient Population | Primary Outcome Measure | Status | Sponsor |
|---|---|---|---|---|---|
| NCT01349075 | TheraSphere (Yttrium-90) | Unresectable HCC | Response to treatment via diagnostic imaging | Recruiting | Thomas Jefferson University |
| NCT02072356 | TheraSphere (Yttrium-90) | Unresectable HCC | Response to treatment; survival time, adverse experiences | Recruiting | Ohio State University Comprehensive Cancer Center |
| NCT00906984 | TheraSphere (Yttrium-90) | Unresectable HCC | Response to treatment via diagnostic imaging | Recruiting | University of California, Irvine |
| NCT01176604 | TheraSphere (Yttrium-90) | Unresectable HCC | Overall survival associated with treatment | Recruiting | M.D. Anderson Cancer Center |
| NCT00877136 | TheraSphere (Yttrium-90) | Unresectable HCC | Evaluate patient quality of life and toxicities associated with treatment | Recruiting | St. Joseph Hospital of Orange |
| NCT01686880† | SIR-Spheres (Yttrium-90) | HCC in cirrhotic liver | Peri-operative morbidity of SIRT prior to surgical resection or radiofrequency | Recruiting | Jules Bordet Institute |
| NCT00956930† | Yttrium-90 glass microspheres vs. TACE (cisplatin, mitomycin, doxorubicin) | Unresectable HCC | Time to progression in patients treated with TACE vs. Y90 via diagnostic imaging | Recruiting | Northwestern University |
| NCT01381211† | TheraSphere (Yttrium-90) vs. TACE-DEB (doxorubicin) | Intermediate HCC | Time to progression | Recruiting | University Hospital, Ghent |
| NCT00846131* | TheraSphere (Yttrium-90) vs. Sorafenib + TheraSphere (Yttrium-90) | Pre-transplant HCC | Evaluate sorafenib as an adjunct to Y-90 for control of HCC as a bridge/downstage to transplant | Ongoing | Northwestern University |
| NCT01900002† | TheraSphere (Yttrium-90) + Sorafenib | Advanced HCC | Toxicity of Sorafenib and Yttrium-90 | Recruiting | M.D. Anderson Cancer Center |
| NCT01556490‡ | Sorafenib vs. TheraSphere (Yttrium-90) + Sorafenib | Unresectable HCC | Overall survival | Recruiting | BTG International Inc. |
| NCT01126645† | RFA followed by sorafenib or placebo (local ablation group) or SIRT + sorafenib or sorafenib alone (palliative treatment group) | Unresectable HCC | Time to recurrence; overall survival; Primovist®-enhanced MRI is non-inferior or superior compared with contrast-enhanced multislice CT | Recruiting | University of Magdeburg |
| NCT01482442‡ | SIR-Spheres (Yttrium-90) vs. Sorafenib | Advanced HCC | Median overall survival time | Recruiting | Assistance Publique - Hopitaux de Paris |
| NCT01135056‡ | SIR-Spheres (Yttrium-90) vs. Sorafenib | Locally advanced HCC | Overall survival | Recruiting | Singapore General Hospital |
| NCT02004210‡ | TACE vs. TARE | Advanced HCC | Overall survival | Recruiting | Seoul National University Hospital |
| NCT00530010 | TheraSphere (Yttrium-90) | Unresectable HCC | Proportion of patients completing scheduled treatment plan | Recruiting | Northwestern University |
| NCT02305459 | TheraSphere (Yttrium-90) + QLQ-C30 with HCC module (Behavorial) | HCC | Change from Baseline in Quality of Life questionnaire QLQ-C30 with HCC Module | Recruiting | Cardiovascular and Interventional Radiological Society of Europe |
| NCT01775280† | Yttrium-90 glass microspheres | Unresectable to borderline resectable HCC | Percentage of patients that can be downstaged to resectability | Recruiting | University of Zurich |
| NCT01798160∥ | TACE-DEB vs. SIR-Spheres (Yttrium-90) | HCC | Progression-free survival; overall survival | Ongoing | Johannes Gutenberg University Mainz |
| NCT01887717‡ | TheraSphere (Yttrium-90) vs. Sorafenib | Advanced HCC with PVT | Overall survival | Recruiting | BTG International Inc. |
*Phase I trials, †Phase II trials, ‡Phase III trials, ∥Phase IV trials. DEB = drug eluting beads, HCC = hepatocellular carcinoma, PVT = portal vein thrombosis, RFA = radiofrequency ablation, SIRT = selective internal radiation therapy, TACE = transarterial chemoembolization, TARE = transarterial radioembolization