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ACTIVE_NOT_RECRUITINGPHASE3

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)

NCT04194775•CStone Pharmaceuticals

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥18 years on the day of signing informed consent-(For Taiwan, the lower limit of age is 20 years).

Exclusion Criteria

•3. With at least one measurable lesion can be assessed
•4. Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1.
•5. Life expectancy ≥ 3 months.
•6. Child-Pugh A
•7. No prior systemic treatment for advanced HCC
•8. Subjects with hepatitis B virus (HBV) infection, are willing to continue receiving antiviral treatment while on study.
•9. Subjects have adequate organ and marrow function. Female subjects with childbearing potential must have negative serum pregnancy test result at screening. Female subjects with childbearing potential, and male subjects and their female partners with childbearing potential must agree to use an contraceptive method(s) from the day of signing informed consent form (ICF), during the study and till at least 6 months after the last dose of study treatment.
•10. Fibrolamellar-HCC, sarcomatoid, cholangiocellular carcinoma or mixed cholangiocarcinoma and HCC.
•11. A prior bleeding event due to esophageal within 6 months or other gastrointestinal bleeding events within 28 days prior to screening.
•12. Malabsorption syndrome or inability to take oral medication due to other causes.
+14 more criteria

Locations (74)

Southern California Research Center

Coronado, California, United States

Inland Empire Liver Foundation

Rialto, California, United States

Mercy Medical Center

Baltimore, Maryland, United States

UMass Memorial Medical Center

Worcester, Massachusetts, United States

Stony Brook University Cancer Clinical Trials

Stony Brook, New York, United States

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

The First Affiliated Hospital Of Anhui Medical University

Hefei, Anhui, China

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Beijing You'an Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Key Dates

Start Date

December 13, 2019

Primary Completion Date

June 18, 2025

Completion Date

September 30, 2026

Last Updated

December 11, 2025

Enrollment

534

ACTUAL participants

Conditions

Hepatocellular Carcinoma

Interventions

Nofazinlimab (CS1003)+Lenvatinib

DRUG

Nofazinlimab (CS1003) Placebo+Lenvatinib

DRUG

Early Detection of Liver Cancer by QUS

NCT06345508

Hepatocellular CarcinomaLiver Cancer

View study

RECRUITINGPHASE1/PHASE2

Testing the Addition of an Anti-cancer Drug, Sapanisertib, to the Usual Chemotherapy Treatment (Cabozantinib) in Metastatic Liver Cell Cancer With a Change in Genes for the Protein β-Catenin, The SAPHIRE Trial

NCT06811116

Advanced Hepatocellular CarcinomaMetastatic Hepatocellular Carcinoma+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Early Detection of Liver Cancer by QUS

Testing the Addition of an Anti-cancer Drug, Sapanisertib, to the Usual Chemotherapy Treatment (Cabozantinib) in Metastatic Liver Cell Cancer With a Change in Genes for the Protein β-Catenin, The SAPHIRE Trial

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

Nivolumab, Fluorouracil, and Interferon Alpha 2B for the Treatment of Unresectable Fibrolamellar Cancer

A Study to Evaluate the Safety and Tolerability of Pumitamig Alone or In Combination With Ipilimumab in Participants With First-Line Advanced or Unresectable Hepatocellular Carcinoma (HCC) (ROSETTA HCC-206)