A Study of Nofazinlimab (CS1003) in Subjects With Advanced Hepatocellular Carcinoma
| 适应症 | Hepatocellular Carcinoma |
|---|---|
| 分期 | 3期 |
| 申办方 | CStone Pharmaceuticals |
| 状态 | 进行中（已停止招募） |
| 受试者人数 | 534 人 |
| 干预（药物） | Nofazinlimab (CS1003)+Lenvatinib, Nofazinlimab (CS1003) Placebo+Lenvatinib |
| 开始日期 | 2019年12月13日 |
| 完成日期 | 2025年6月18日 |
| 结果公布日 | 2026年7月30日 |
摘要
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 |
在 BENITIONS 中查看 查看 ClinicalTrials.gov 原文
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