Ongoing studies of SIR-Spheres® Y-90 resin microspheres in the treatment of mCRC

Title Setting Sponsor Study ID Treatment Arm(s) N Location
SIRFLOX
www.sirflox.com
FOLFOX + SIR-Spheres microspheres versus FOLFOX alone in patients with liver metastases from primary colorectal cancer
1st-line colorectal cancer SIRTEX NCT00724503 FOLFOX (± bevacizumab) versus FOLFOX (± bevacizumab) + SIR-Spheres microspheres 530 Global
FOXFIRE
An open-label trial of 5-fluorouracil, oxaliplatin and folinic acid with or without interventional radioembolisation as first-line treatment for patients with unresectable liver-only or liver-predominant metastatic colorectal cancer
1st-line colorectal cancer Collaborative Group Study ISRCTN83867919 OxMdG (± biologic agent) versus OxMdG (± biologic agent) + SIR-Spheres microspheres ≥360 UK
FOXFIRE Global
http://foxfireglobal.sirtex.com/ FOLFOX6m + SIR Spheres microspheres versus FOLFOX6m alone in patients with liver metastases from primary colorectal cancer
1st-line colorectal cancer SIRTEX NCT01721954 FOLFOX (± bevacizumab) versus FOLFOX (± bevacizumab) + SIR Spheres microspheres ≥200 Global
SIR-step
A randomised study comparing hepatic arterial injection of Yttrium-90 resin microspheres (SIR-Spheres microspheres) plus systemic maintenance therapy versus systemic maintenance therapy alone for patients with unresectable liver metastases from colorectal cancer which are controlled after induction systemic therapy
1st-line colorectal cancer Collaborative Group Study NCT01895257 1st-line chemotherapy (3 months) followed by: 5FU/LV (± bevacizumab) versus 1st-line chemotherapy (3 months) followed by 5FU/LV (± bevacizumab) + SIR-Spheres microspheres 162 Europe
A two arm safety study of regorafenib before or after SIR-Spheres microspheres (90Y) for the treatment of patients with refractory metastatic colorectal cancer and liver metastases Refractory metastatic colorectal cancer Investigator Initiated NCT02195011 regorafenib > SIR-Spheres microspheres > regorafenib versus SIR-Spheres microspheres > regorafenib 50 USA
HITM-SIR
CAR-T Hepatic Artery Infusions and SIR-Spheres microspheres for liver metastases
Adenocarcinoma Investigator Initiated NCT02416466 anti-CEA CAR-T cells > SIR-Spheres Y-90 resin microspheres 6 USA


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