Table 2.
Current randomized clinical trials of 90Y microspheres for primary or secondary liver tumors
| Trial | Location | Intervention arms | Primary endpoint | n |
|---|---|---|---|---|
| mCRC (first line) | ||||
| SIRFLOX85 | Global | FOLFOX ± bevacizumab FOLFOX ± bevacizumab + SIR-Spheres |
PFS | 530 |
| FOXFIRE86 | UK | FOLFOX ± biological agent FOLFOX ± biological agent + SIR-Spheres |
OS | 320 |
| FOXFIRE Global95 | Global | FOLFOX ± bevacizumab FOLFOX ± bevacizumab + SIR-Spheres |
OS | 200 |
| mCRC (first line after PR/SD following 3-6 months of induction chemotherapy) | ||||
| SIR-step96 | Belgium | 5FU/LV ± biological agent 5FU/LV ± biological agent + SIR-Spheres |
TTP | 162 |
| mCRC (second line) | ||||
| EPOCH87 | Global | Standard of care chemotherapy Standard of care chemotherapy + TheraSphere |
PFS | 340 |
| HCC | ||||
| SIRveNIB90 | Global | Sorafenib SIRT with SIR-Spheres |
OS | 360 |
| SARAH92 | France | Sorafenib SIRT with SIR-Spheres |
OS | 496 |
| SORAMIC91 | Germany | RFA ± Sorafenib Sorafenib ± SIRT with SIR-Spheres |
TTR/OS | 665 |
| STOP-HCC88 | Global | Sorafenib Sorafenib + SIRT with TheraSphere |
OS | 390 |
| DOSISPHERES-0197 | France | Standard dosimetry SIRT with TheraSphere Optimized dosimetry SIRT with TheraSphere |
ORR | 210 |
| PREMIERE98 | US | TACE SIRT with TheraSphere |
TTP | 124 |
| TRACE99 | Belgium | TACE-DEB SIRT with TheraSphere |
TTP | 140 |
| HCC with PVT | ||||
| YES-P89 | Global | Sorafenib SIRT with TheraSphere |
OS | 328 |
| ICC | ||||
| NCT01798147100 | Germany | TACE-DEB SIRT with SIR-Spheres |
PFS | 24 |
DEB, drug-eluting beads; FOLFOX, leucovorin + fluorouracil + oxaliplatin; 5FU, fluorouracil; HCC, hepatocellular carcinoma; ICC, intrahepatic cholangiocarcinoma; LV, leucovorin; mCRC, metastatic colorectal cancer; PVT, portal vein thrombosis; RFA; radiofrequency ablation; SIRT, selective internal radiation therapy; TACE, transarterial chemoembolization; TTR, time to recurrence.