A Study of Nofazinlimab (CS1003) in Subjects With Advanced Hepatocellular Carcinoma
NCT ID: NCT04194775
Last Updated: 2025-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
534 participants
INTERVENTIONAL
2019-12-13
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Nofazinlimab (CS1003)
Nofazinlimab (CS1003)+Lenvatinib
Nofazinlimab (CS1003), intravenous (i.v.) administration every 21 days; Lenvatinib oral administration, once daily
Nofazinlimab (CS1003) placebo
Nofazinlimab (CS1003) Placebo+Lenvatinib
Nofazinlimab (CS1003) Placebo, i.v. administration every 21 days ; Lenvatinib oral administration, once daily
Interventions
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Nofazinlimab (CS1003)+Lenvatinib
Nofazinlimab (CS1003), intravenous (i.v.) administration every 21 days; Lenvatinib oral administration, once daily
Nofazinlimab (CS1003) Placebo+Lenvatinib
Nofazinlimab (CS1003) Placebo, i.v. administration every 21 days ; Lenvatinib oral administration, once daily
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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CStone Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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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
Padua, 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
Countries
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Other Identifiers
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CS1003-305
Identifier Type: -
Identifier Source: org_study_id
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