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ACTIVE NOT RECRUITING
NCT05016245
PHASE3

MANDARIN (S6371)

Sponsor: Boston Scientific Corporation

View on ClinicalTrials.gov

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

Interventions

COMBINATION_PRODUCT

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

PROCEDURE

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