NCT04194775

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

A Multi-Center, Double-Blind, Randomized, Phase III Study to Investigate the Efficacy and Safety of Nofazinlimab (CS1003) in Combination With Lenvatinib Compared to Placebo in Combination With Lenvatinib as First-Line Therapy in Subjects With Advanced Hepatocellular Carcinoma (HCC)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 534 (actual)
• Sponsor: CStone Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 of and lenvatinib is selected as the basic treatment for HCC.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Nofazinlimab (CS1003)+Lenvatinib	Nofazinlimab (CS1003), intravenous (i.v.) administration every 21 days; Lenvatinib oral administration, once daily
DRUG	Nofazinlimab (CS1003) Placebo+Lenvatinib	Nofazinlimab (CS1003) Placebo, i.v. administration every 21 days ; Lenvatinib oral administration, once daily

Timeline

• Start date: 2019-12-13
• Primary completion: 2025-06-18
• Completion: 2026-09-30
• First posted: 2019-12-11
• Last updated: 2025-12-11

Locations

74 sites across 6 countries: United States, China, Italy, Poland, Spain, Taiwan

Regulatory

• FDA-regulated drug study