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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 for inoperable hepatocellular carcinoma, a type of liver cancer. It is an investigational therapy being developed by Boston Scientific Corporation. The treatment involves delivering radioactive microspheres directly to the tumor, and it is currently in Phase 3 clinical development.
TheraSphere Yttrium-90 Glass Microspheres targets liver tumors by delivering yttrium-90, a radioactive isotope, directly to the site of the cancer. The microspheres are injected into the hepatic artery, where they become lodged in the tumor's blood vessels and emit radiation to destroy cancer cells while sparing healthy tissue.
TheraSphere Yttrium-90 Glass Microspheres is developed by Boston Scientific Corporation, a medical device company traded on the New York Stock Exchange under the ticker BSX. The company is conducting clinical trials to evaluate the treatment for inoperable hepatocellular carcinoma.
TheraSphere Yttrium-90 Glass Microspheres is in Phase 3 clinical development. It is an investigational therapy and has not been approved by regulatory authorities. A Phase 3 trial, known as MANDARIN (NCT05016245), has been completed, evaluating the treatment in patients with inoperable hepatocellular carcinoma.
TheraSphere Yttrium-90 Glass Microspheres has one completed Phase 3 clinical trial, MANDARIN (NCT05016245). This randomized, active-controlled study enrolled 92 patients with inoperable hepatocellular carcinoma in China. The trial was open to adults aged 18 years and older, and it did not use a biomarker for patient selection.
No, TheraSphere Yttrium-90 Glass Microspheres is not the same as SIR-Spheres. While both are yttrium-90 microsphere therapies used for liver cancer, they are distinct products. TheraSphere is developed by Boston Scientific, whereas SIR-Spheres is a different product from another manufacturer. The two are not interchangeable.