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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07511504 | Y-90 Radioembolization, Durvalumab, Tremelimumab, and Zanzalintinib for the Treatment of Unresectable and Locally-Advanced Hepatocellular Carcinoma | PHASE2 | NOT YET_RECRUITING | 40 | — | — | Apr 2, 2026 | Aug 1, 2027 | Apr 6, 2026 | 1 | United States |
Will be reported with 95% exact confidence interval.
| Arm | Type | Description |
|---|---|---|
| Treatment (Y-90, tremelimumab, durvalumab, zanzalintinib) | EXPERIMENTAL | CYCLE 1: Patients receive tremelimumab IV and durvalumab IV, over 60 minutes, on day 1. 7-14 days later patients undergo transarterial radioembolization with Y-90 in the absence of disease progression or unacceptable toxicity. 7 days to 12 weeks later patients proceed to cycle 2. CYCLE 2-12: Patients receive durvalumab IV, over 30-60 minutes, on day 1 and zanzalintinib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo angiogram during screening and undergo SPECT, CT scan or MRI, and blood and urine sample collection throughout the study. Patients optionally undergo tumor biopsy throughout the study. |
| Name | Type | Description |
|---|---|---|
| Angiogram | PROCEDURE | Undergo angiogram |
| Biopsy Procedure | PROCEDURE | Undergo tumor biopsy |
| Biospecimen Collection | PROCEDURE | Undergo blood and urine sample collection |
| Computed Tomography | PROCEDURE | Undergo CT scan |
| Durvalumab | BIOLOGICAL | Given IV |
| Magnetic Resonance Imaging | PROCEDURE | Undergo MRI |
| Single Photon Emission Computed Tomography | PROCEDURE | Undergo SPECT |
| Tremelimumab | BIOLOGICAL | Given IV |
| Yttrium-90 Microsphere Radioembolization | PROCEDURE | Given via transartieral radioembolization procedure |
| Zanzalintinib | DRUG | Given PO |
Inclusion Criteria: * Participant must provide written informed consent before any study-specific procedures or interventions are performed * Participants aged ≥ 18 years * Body weight \> 30 kg * Patients must have radiologically, or histologically or cytologically confirmed hepatocellular cancer t...