A Study of Nofazinlimab (CS1003) in Subjects With Advanced Hepatocellular Carcinoma
| Condition | Hepatocellular Carcinoma |
|---|---|
| Phase | Phase 3 |
| Sponsor | CStone Pharmaceuticals |
| Status | Active, not recruiting |
| Enrollment | 534 participants |
| Interventions | Nofazinlimab (CS1003)+Lenvatinib, Nofazinlimab (CS1003) Placebo+Lenvatinib |
| Start date | Dec 13, 2019 |
| Completion date | Jun 18, 2025 |
| Results posted | Jul 30, 2026 |
Summary
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 |
Open in BENITIONS View on ClinicalTrials.gov
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