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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05063565 | TheraSphere With Durvalumab and Tremelimumab for HCC | PHASE2 | ACTIVE NOT_RECRUITING | 100 | — | — | Nov 3, 2023 | Jun 1, 2027 | Jun 1, 2026 | 36 | United States, France +3 |
Complete response and partial response evaluated by mRECIST.
| Arm | Type | Description |
|---|---|---|
| TheraSphere followed by Durvalumab and Tremelimumab | EXPERIMENTAL | TheraSphere followed by Tremelimumab plus Durvalumab administered once, then repeated administration of Durvalumab monthly up 18 months. |
| Name | Type | Description |
|---|---|---|
| TheraSphere Y-90 glass microsphere therapy | DEVICE | TheraSphere Y-90 glass microsphere therapy administered through the hepatic artery at index procedure. |
| Durvalumab (Imfinzi) immunotherapy | DRUG | 1500 mg, every 4 weeks that continues for a maximum duration of 18 months or until confirmed progression (by site assessment), unacceptable toxicity, study withdrawal, or study early termination by the sponsor. Treatment beyond confirmed radiographic progression is permitted per patient consent if the following criteria are met: * Absence of clinical symptoms or signs indicating clinically significant disease progression * No decline in performance status * Absence of rapid disease progression or threat to vital organs or critical anatomical sites (i.e. new CNS metastasis, respiratory failure due to tumor compression, spinal cord compression) requiring urgent alternative medical intervention * No other treatment discontinuation criteria are met |
| Tremelimumab immunotherapy | DRUG | 300 mg, single administration |
Inclusion Criteria: 1. Participants must be aged ≥18 years at the time of screening. 2. Written informed consent and any locally required authorization (e.g., Health Insurance Portability and accountability Act in the US, European Union (EU) data privacy regulations in the EU) obtained from the pat...