A Study of Nofazinlimab (CS1003) in Subjects With Advanced Hepatocellular Carcinoma
| 대상 질환 | Hepatocellular Carcinoma |
|---|---|
| 임상 단계 | 3상 |
| 스폰서 | CStone Pharmaceuticals |
| 상태 | 진행 중(모집 완료) |
| 참여자 수 | 534 명 |
| 중재(약물) | Nofazinlimab (CS1003)+Lenvatinib, Nofazinlimab (CS1003) Placebo+Lenvatinib |
| 시작일 | 2019년 12월 13일 |
| 완료일 | 2025년 6월 18일 |
| 결과 공개일 | 2026년 7월 30일 |
요약
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 |
BENITIONS에서 보기 ClinicalTrials.gov 원문 보기
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