Nofazinlimab + Lenvatinib for Liver Cancer

Recruiting in Palo Alto (17 mi)

+77 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: CStone Pharmaceuticals

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

Adults with advanced hepatocellular carcinoma (HCC) who haven't had systemic treatment and can't have surgery or locoregional therapy. They should be in relatively good health, not pregnant, agree to use contraception, and have no history of certain cancers or serious diseases that could affect the trial's outcome.

Inclusion Criteria

I am at least 18 years old (20 if I'm in Taiwan).

My liver cancer cannot be removed by surgery and is in an advanced stage.

I am not pregnant and agree to use birth control during and 6 months after the study.

Exclusion Criteria

I cannot take pills because my body doesn't absorb nutrients well or for another reason.

I have been diagnosed with HIV/AIDS.

I had surgery or local therapy for symptom relief within the last 4 weeks.

Treatment Details

Interventions

• Nofazinlimab (CS1003) (Monoclonal Antibodies)

Trial Overview The study is testing Nofazinlimab combined with Lenvatinib versus a placebo combined with Lenvatinib in treating HCC. Participants are randomly assigned to either group in this double-blind phase III trial to compare effectiveness and safety.

Participant Groups

Group I: Nofazinlimab (CS1003) Experimental Treatment 1 Intervention

Group II: Nofazinlimab (CS1003) placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

CStone Pharmaceuticals

Lead Sponsor

Trials

28

Recruited

4,100+