Approval Probability
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TheraSphere Yttrium-90 Glass Microspheres · 1 trial · 1 indication
Time to progression (TTP) Definition of progression: Progressive Disease (PD) assessment occurs according to mRECIST occurs according to mRECIST
| Arm | Type | Description |
|---|---|---|
| TheraSphere™ Yttrium-90 Glass Microspheres | EXPERIMENTAL | - |
| conventional Transarterial Chemoembolization(cTACE) | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| TheraSphere™ Yttrium-90 Glass Microspheres | COMBINATION_PRODUCT | 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) | PROCEDURE | 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. |
Inclusion Criteria: * ≥18 and ≤80 age and provided study consent * Patients diagnosed with HCC and clinically evaluated as inoperable (as per local practice) or who refuse operation (ablation, hepatectomy and liver transplantation) * At least one well defined HCC tumor measurable by mRECIST in cont...
TheraSphere Yttrium-90 Glass Microspheres is used to treat inoperable hepatocellular carcinoma, a form of liver cancer that cannot be removed with surgery. It is a liver-directed therapy being studied in a Phase 3 clinical program for this indication.
TheraSphere Yttrium-90 Glass Microspheres is developed by Boston Scientific Corporation, which trades on the New York Stock Exchange under the ticker BSX. The company is responsible for the clinical development of the product.
TheraSphere Yttrium-90 Glass Microspheres is in Phase 3 clinical development. It is an investigational product and has not been approved by the FDA for the studied indication. The Phase 3 trial has been completed.
TheraSphere Yttrium-90 Glass Microspheres has been studied in the Phase 3 MANDARIN (S6371) trial, registered as NCT05016245. The trial enrolled 92 participants with inoperable hepatocellular carcinoma in China and has been completed.
Yes, TheraSphere Yttrium-90 Glass Microspheres is also known as TheraSphere. The full name includes the trademark symbol and describes the yttrium-90 glass microsphere composition. Both names refer to the same product developed by Boston Scientific.