Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
Phase 3
Active, not recruiting
NCT03298451
| Condition | Hepatocellular Carcinoma |
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| Phase | Phase 3 |
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| Sponsor | AstraZeneca |
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| Status | Active, not recruiting |
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| Enrollment | 1,324 participants |
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| Interventions | Durvalumab, Tremelimumab (Regimen 1), Tremelimumab (Regimen 2), Sorafenib, Durvalumab (Regimen 1) |
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| Start date | Oct 11, 2017 |
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| Completion date | Aug 27, 2021 |
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| Results posted | Jun 18, 2023 |
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Summary
This is a randomized, open-label, multi-center, global, Phase III study to assess the efficacy and safety of durvalumab plus tremelimumab combination therapy and durvalumab monotherapy versus sorafenib in the treatment of patients with no prior systemic therapy for unresectable HCC. The patients cannot be eligible for locoregional therapy
Overall Survival (OS) - Treme 300 mg x1 Dose + Durva 1500 mg vs Sora 400 mg
From the date of randomization until death due to any cause, assessed up to the data cut-off date (27Aug2021, to a maximum of approximately 46 months). · months
| Durva 1500 mg | 16.56 months |
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| Treme 300 mg x1 Dose + Durva 1500 mg | 16.43 months |
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| Treme 75 mg x4 Doses + Durva 1500 mg | 16.36 months |
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| Sora 400 mg | 13.77 months |
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Open in BENITIONS
View on ClinicalTrials.gov
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