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


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