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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Hepatocellular Carcinoma

In brief

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.

Key facts

Study ID

NCT04194775

Run by

CStone Pharmaceuticals

People needed

534

Starts

2019-12-13

Expected to finish

2026-09-30

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥18 years on the day of signing informed consent-(For Taiwan, the lower limit of age is 20 years).
• Subjects with unresectable advanced HCC, that is not eligible for surgery and/or locoregional therapy (Stage B or C based on Barcelona Clinic Liver Cancer [BCLC] staging system, and meets either one of the following criteria: 1) histologically or cytologically confirmed diagnosis of HCC, 2) clinically confirmed diagnosis of HCC according to American Association for the Study of Liver Diseases (AASLD) criteria. Patients without cirrhosis require histological confirmation of diagnosis.
• With at least one measurable lesion can be assessed
• Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1.
• Life expectancy ≥ 3 months.
• Child-Pugh A
• No prior systemic treatment for advanced HCC
• Subjects with hepatitis B virus (HBV) infection, are willing to continue receiving antiviral treatment while on study.
• 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.

You may not qualify if…

• Fibrolamellar-HCC, sarcomatoid, cholangiocellular carcinoma or mixed cholangiocarcinoma and HCC.
• A prior bleeding event due to esophageal within 6 months or other gastrointestinal bleeding events within 28 days prior to screening.
• Malabsorption syndrome or inability to take oral medication due to other causes.
• HBV and HCV co-infection.
• Investigator evaluates to increase the drug related risk caused by enrolling subjects in trial and taking study drug, or any serious or uncontrolled systematic disease that confound the drug absorption or the study outcome, e,g diabetes mellitus, hypertension, rheumatoid arthritis, major cardiovascular disease and so on.
• Surgery or locoregional therapy for palliative purpose within 4 weeks prior to study treatment.
• History of other malignancy(ies) in the past 5 years, except for malignant disease treated with curative intent and without active disease.
• Known history of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).
• Current or prior use of systemic corticosteroid (> 10 mg/day prednisone or equivalent) or other immunosuppressive medication within 14 days prior to the first dose of study treatment.
• History of bone marrow transplantation or organ transplantation.
• History of anaphylaxis or hypersensitivity to any ingredient of the investigational product.
• Any contraindication of lenvatinib.
• Known history of drugs abuse that would interfere with cooperation with the requirements of the trial.
• Pregnant or lactating female subjects.
• History of psychiatric disease that would interfere with cooperation with the requirements of the trial; lack of or with restricted physical capability.
• QTc interval > 470 msec (as calculated with Fridericia's formula) at screening electrocardiogram (ECG);
• Any condition that would in the investigator's judgment, prevent the subject from participating in this study.

Where it is running

• 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
• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China
• The 900th Hospital of Joint Logistic Support Force of PLA — Fuzhou, Fujian, China
• The First Affiliated Hospital of Xiamen University — Xiamen, Fujian, China
• Foshan First People's Hospital — Foshan, Guangdong, China
• Nanfang Hospital — Guangzhou, Guangdong, China
• The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine — Guangzhou, Guangdong, China
• Guangxi Medical University Affiliated Tumor Hospital — Nanning, Guangxi, China
• Hainan General Hospital - Hepatology — Haikou, Hainan, China
• Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China
• Luoyang Central Hospital — Luoyang, Henan, China
• Henan Cancer Hospital — Zhengzhou, Henan, China
• Zhengzhou University - First Affiliated Hospital — Zhengzhou, Henan, China
• hubei Cancer Hospital — Wuhan, Hubei, China
• Tongji Hospital - Medical Oncology — Wuhan, Hubei, China
• Hunan Cancer Hospital - Radiology — Changsha, Hunan, China
• Southern California Research Center — Coronado, California, United States

Full record on ClinicalTrials.gov

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