A Study of Nofazinlimab (CS1003) in Subjects With Advanced Hepatocellular Carcinoma
| Заболевание | Hepatocellular Carcinoma |
|---|---|
| Фаза | Фаза 3 |
| Спонсор | CStone Pharmaceuticals |
| Статус | Идёт, набор закрыт |
| Участники | 534 участн. |
| Вмешательство | Nofazinlimab (CS1003)+Lenvatinib, Nofazinlimab (CS1003) Placebo+Lenvatinib |
| Дата начала | 13.12.2019 |
| Дата завершения | 18.06.2025 |
| Публикация результатов | 30.07.2026 |
Кратко
This is a multi-center, double-blind, randomized, phase III study to investigate the efficacy and safety of Nofazinlimab (CS1003) in combination with lenvatinib and placebo in combination with lenvatinib in the treatment of subjects with no prior systemic treatment and with unresectable advanced hepatocellular carcinoma (HCC). Subjects cannot be eligible for locoregional therapy. In this study, Nofazinlimab (CS1003) (or placebo) and lenvatinib are both considered as the study treatment while Nofazinlimab (CS1003) (or placebo) is the investigational product and lenvatinib is selected as the basic treatment for HCC.
Overall Survival (OS)
| Nofazinlimab + Lenvatinib | 21.6 months |
|---|---|
| Placebo + Lenvatinib | 18.5 months |
Открыть в BENITIONS Открыть на ClinicalTrials.gov
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