Evaluate Durvalumab and Tremelimumab +/- Lenvatinib in Combination With TACE in Patients With Locoregional HCC
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- AstraZeneca
- Study ID
- NCT05301842
- Phase
- PHASE3
- Status
- Active Not Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 120 Years
- Healthy Volunteers
- Not accepted
Interventions
- Tremelimumab — DRUGTremelimumab IV (intravenous)
- Durvalumab — DRUGDurvalumab IV (intravenous)
- Transarterial Chemoembolization (TACE) — PROCEDURETACE (chemo and embolic agent injection into the hepatic artery)
- Lenvatinib — DRUGLenvatinib (oral)
Study Details
A global study to evaluate transarterial chemoembolization (TACE) in combination with durvalumab, tremelimumab and lenvatinib therapy in patients with locoregional hepatocellular carcinoma
Key Dates
- Start date
- Mar 28, 2022
- Status verified
- Apr 2026
- Primary completion
- Feb 23, 2026
- Completion
- Feb 26, 2027
Study Design
- Enrollment
- 760 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Arm ATremelimumab, Durvalumab and Lenvatinib in combination with Transarterial Chemoembolization (TACE)
- Experimental: Arm BTremelimumab and Durvalumab in combination with Transarterial Chemoemobolization (TACE)
- Active Comparator: Arm CTransarterial Chemoembolization (TACE)
Primary Outcome Measure
Progression Free Survival (PFS) for Arm A vs Arm C [ Time Frame: Approximately 5 years ]
Locations (12)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Research Site | Birmingham | Alabama | 35233 | - |
| Research Site | Mobile | Alabama | 36607 | - |
| Research Site | Yuma | Arizona | 85364 | - |
| Research Site | Glendale | California | 91204 | - |
| Research Site | Atlanta | Georgia | 30318 | - |
| Research Site | Baltimore | Maryland | 21201 | - |
| Research Site | Santa Fe | New Mexico | 87505 | - |
| Research Site | Commack | New York | 11725 | - |
| Research Site | New York | New York | 10029 | - |
| Research Site | Memphis | Tennessee | 38104 | - |
| Research Site | Dallas | Texas | 75235 | - |
| Research Site | Houston | Texas | 77030 | - |
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