Clinical Trial

A Study of Nofazinlimab (CS1003) in Subjects With Advanced Hepatocellular Carcinoma

Active, Not Recruiting Phase 3
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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.
Protocol Amendment History 11 amendments
This ClinicalTrials.gov record has been amended 11 times since 2019-12-10; most recent amendment 2026-06-05.
Status change: Recruiting → Active, Not Recruiting 2022-10-28
Status change: Not Yet Recruiting → Recruiting 2020-01-17
Trial Details
NCT Number NCT04194775
Lead Sponsor CStone Pharmaceuticals
Conditions Hepatocellular Carcinoma
Enrollment 534 participants
Start Date 2019-12-13
Primary Completion 2025-06-18 (estimated)
Study Completion 2026-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-30