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MANDARIN (S6371)
Sponsor: Boston Scientific Corporation
Summary
To evaluate the efficacy and safety of TheraSphereTM yttrium \[90Y\] glass microsphere in the Chinese patients with inoperable hepatocellular carcinoma.
Official title: A Multicentre, Prospective, Open-label, Randomized Controlled Trial on the Efficacy and Safety of TheraSphereTM (Yttrium-90 Glass Microspheres) Compared to Conventional Transarterial Chemoembolization (cTACE) in Chinese Patients With Inoperable Hepatocellular Carcinoma
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
92
Start Date
2021-09-13
Completion Date
2026-10-30
Last Updated
2026-04-08
Healthy Volunteers
No
Conditions
Interventions
TheraSphere™ Yttrium-90 Glass Microspheres
TheraSphere™ Yttrium-90 Glass Microspheres TheraSphere™ is steam sterilized and supplied in 6 standard dose sizes: 3 GBq, 5 GBq, 7 GBq, 10 GBq, 15 GBq, 20 GBq. Custom dose sizes are also available in 0.5 GBq increments between 3 and 20 GBq. TheraSphereTM is supplied with the following accessories: Administration Set Administration Accessory Kit
conventional Transarterial Chemoembolization(cTACE)
conventional Transarterial Chemoembolization(cTACE) is comprised of an anti-neoplastic agent(s) (i.e. cisplatin), lipiodol and embolic agent(s). The choice of agent(s) to be used is per usual local site practice. Chemotherapy agents can be as a single agent or used in combination, as per local practice.
Locations (1)
Zhongda Hospital Southeast University
Nanjing, Jiangsu, China