Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05016245 | MANDARIN (S6371) | PHASE3 | ACTIVE NOT_RECRUITING | 92 | — | — | Sep 13, 2021 | Oct 30, 2026 | Jun 8, 2026 | 1 | China |
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...