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NCT04194775

PHASE3

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

Sponsor: 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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

534

Start Date

2019-12-13

Completion Date

2026-09-30

Last Updated

2025-12-11

Healthy Volunteers

Conditions

Hepatocellular Carcinoma

Interventions

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

Inclusion criteria 1. Age ≥18 years on the day of signing informed consent-(For Taiwan, the lower limit of age is 20 years). 2. 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. 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. Exclusion criteria 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. 13. HBV and HCV co-infection. 14. 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. 15. Surgery or locoregional therapy for palliative purpose within 4 weeks prior to study treatment. 16. History of other malignancy(ies) in the past 5 years, except for malignant disease treated with curative intent and without active disease. 17. Known history of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS). 18. 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. 19. History of bone marrow transplantation or organ transplantation. 20. History of anaphylaxis or hypersensitivity to any ingredient of the investigational product. 21. Any contraindication of lenvatinib. 22. Known history of drugs abuse that would interfere with cooperation with the requirements of the trial. 23. Pregnant or lactating female subjects. 24. History of psychiatric disease that would interfere with cooperation with the requirements of the trial; lack of or with restricted physical capability. 25. QTc interval \> 470 msec (as calculated with Fridericia's formula) at screening electrocardiogram (ECG); 26. Any condition that would in the investigator's judgment, prevent the subject from participating in this study.

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

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

Hunan Provincial People's Hospital

Changsha, Hunan, China

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

The First People's Hospital of Huai'an

Huai'an, Jiangsu, China

Nantong Tumor Hospital

Nantong, Jiangsu, China

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Xuzhou Central Hospital

Xuzhou, Jiangsu, China

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Yanbian University Hospital

Yanbian, Jilin, China

Jinan Military Region General Hospital of the People's Liber

Jinan, Shandong, China

Shangdong Provicial Qianfoshan Hospital

Jinan, Shandong, China

Affiliated Hospital Of Jining Medical University

Jining, Shandong, China

Linyi Cancer Hospital

Linyi, Shandong, China

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Shanghai Cancer Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Shanghai Eastern Hepatobiliary Surgery Hospital - Hepatology

Shanghai, Shanghai Municipality, China

Shanghai First People's Hospital

Shanghai, Shanghai Municipality, China

Sichuan University - West China Hospital

Chengdu, Sichuan, China

Tianjin Medical University - Cancer Institute & Hospital - Oncology

Tianjin, Tianjin Municipality, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Azienda Unità Locale Socio Sanitaria n. 1 Dolomiti, Distretto di Feltre, Ospedale di Feltre

Feltre, Belluno, Italy

Istituto Oncologico Veneto IOV IRCCS - Medical Oncology Unit 1

Padova, Veneto, Italy

Casa di Cura Dott. Pederzoli S.p.A (Ospedale Pederzoli)

Peschiera del Garda, Verona, Italy

PO di Cremona, ASST di Cremona - Oncologia - Cremona - Radiology

Cremona, Italy

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

MED-POLONIA Sp.z o.o.

Poznan, Greater Poland Voivodeship, Poland

Centrum Badan Klinicznych

Wroclaw, Lower Silesian Voivodeship, Poland

Centrum Onkologii im. prof. F. Lukaszczyka

Bydgoszcz, Poland

Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy

Warsaw, Poland

Complexo Hospitalario Universitario A Coruña

A Coruña, Galicia, Spain

Complejo Hospitalario Universitario de Orense

Ourense, Galicia, Spain

Hospital Universitario Puerta De Hierro De Majadahonda

Majadahonda, Madrid, Spain

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

Hospital Ntra. Sra. de Sonsoles

Ávila, Spain

Hospital Del Mar

Barcelona, Spain

H.U. de Burgos

Burgos, Spain

ICO-Hospital Universitari de Girona Dr. Josep Trueta

Girona, Spain

Hospital General Universitario Gregorio Marañón

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

H.U.V.Arrixaca

Murcia, Spain

Hospital Universitario Virgen De La Macarena

Seville, Spain

Consorcio Hospital General Universitario de Valencia

Valencia, Spain

Hospital Unviersitario Miguel Servet

Zaragoza, Spain

China Medical University Hospital - Internal Medicine - Taichung

Taichung, Taiwan

Taichung Veterans General Hospital - Gastroenterology

Taichung, Taiwan

Chi Mei Hospital, Liouying - Department of Oncology

Tainan, Taiwan

Chi Mei Medical Center - YongKang - Gastroenterology - Gastroenterology

Tainan, Taiwan

National Cheng Kung University Hospital - Internal Medicine

Tainan, Taiwan

Tri-Service General Hospital - Neihu Branch - Pulmonary

Taipei, Taiwan

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (74)