Published Data in Intrahepatic Cholangiocarcinoma
In the treatment of progressive or chemorefractory unresectable intrahepatic cholangiocarcinoma (ICC), a prospective study evaluated SIR-Spheres® Y-90 resin microspheres as a well-tolerated and efficacious treatment option. The study included patients with bilobar disease, substantial tumour burden and liver involvement, extra-hepatic metastases, infiltrative disease, and/or an Eastern Cooperative Oncology Group (ECOG) performance status of 0–2.1
Disease control rates of up to 79% have been reported with SIR-Spheres Y-90 resin microspheres for ICC.2 Survival rates after 1, 2 and 3 years of 40%, 27%, and 13%, respectively, were reported in patients with unresectable nodular ICC who failed chemotherapy and/or recurred following surgical resection treated with SIR-Spheres Y-90 resin microspheres.1 Survival may be more favourable when patients have an ECOG performance status of 0 vs. ≥1, a peripheral morphological tumour type,1 or prior treatment with transarterial chemoembolisation (TACE).2 However, survival was not significantly affected by presence or absence of extrahepatic metastasis; tumour burden ≤25% vs. 26-50%; or bilobar vs. unilobar tumour distribution.1
SIRT with SIR-Spheres Y-90 resin microspheres is an efficacious treatment for unresectable ICC, with an acceptable adverse event profile.
Summary of SIR-Spheres Y-90 resin microspheres in ICC
1 Saxena A et al. Ann Surg Oncol 2010; 17: 484-491.
2 Rafi S et al. Cardiovasc Intervent Radiol 2013; 36: 440-448.
Ongoing ICC Studies
Ongoing studies of SIR-Spheres® Y-90 resin microspheres in the treatment of ICC:
| Title | Setting | Sponsor | Study ID | Treatment Arm(s) | N | Location |
|---|---|---|---|---|---|---|
| SIRCCA The study will evaluate the benefit of applying Selective Internal Radiation Therapy (SIRT) using SIR-Spheres Y-90 resin microspheres prior to receiving systemic chemotherapy treatment (cisplatin-gemcitabine, or CIS-GEM) in patients with unresectable intrahepatic cholangiocarcinoma |
Intra-hepatic cholangiocarcinoma | Sirtex | NCT02807181 | SIR-Spheres Y-90 resin microspheres > cisplatin + gemcitabine vs. cisplatin + gemcitabine | 180 | Global |
| Selective internal radiotherapy (SIRT) versus transarterial chemoembolisation (TACE) for the treatment of cholangiocellular carcinoma (CCC). | Intra-hepatic cholangiocarcinoma | Johannes Gutenberg University Mainz | NCT01798147 | SIR-Spheres Y-90 resin microspheres vs. TACE (DEBDOX) | 24 | Germany |
| STOCS This study aims to study the benefits of sequential administration of SIRT followed by standard chemotherapy for treatment of inoperable intrahepatic cholangiocarcinoma. |
Intra-hepatic cholangiocarcinoma | Investigator Initiated | NCT02167711 | SIR-Spheres Y-90 resin microspheres > gemcitabine + cisplatin | 24 | Hong Kong, Singapore |
| 90Y transarterial radioembolisation (TARE) plus gemcitabine and cisplatin in unresectable intrahepatic cholangiocarcinoma | Intra-hepatic cholangiocarcinoma | Investigator Initiated | NCT02512692 | SIR-Spheres Y-90 resin > cisplatin + gemcitabine | 20 | USA |