BENITIONSClinical Trial Intelligence

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

Phase 3 Active, not recruiting NCT04194775

ConditionHepatocellular Carcinoma
PhasePhase 3
SponsorCStone Pharmaceuticals
StatusActive, not recruiting
Enrollment534 participants
InterventionsNofazinlimab (CS1003)+Lenvatinib, Nofazinlimab (CS1003) Placebo+Lenvatinib
Start dateDec 13, 2019
Completion dateJun 18, 2025
Results postedJul 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)

From enrollment to end of follow-up, a median of 42.5 months · months

Nofazinlimab + Lenvatinib21.6 months
Placebo + Lenvatinib18.5 months

Open in BENITIONS View on ClinicalTrials.gov

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