A Study of Nofazinlimab (CS1003) in Subjects With Advanced Hepatocellular Carcinoma
- Conditions
- Hepatocellular Carcinoma
- Interventions
- Drug: Nofazinlimab (CS1003)+LenvatinibDrug: Nofazinlimab (CS1003) Placebo+Lenvatinib
- Registration Number
- NCT04194775
- Lead Sponsor
- CStone Pharmaceuticals
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 534
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nofazinlimab (CS1003) Nofazinlimab (CS1003)+Lenvatinib - Nofazinlimab (CS1003) placebo Nofazinlimab (CS1003) Placebo+Lenvatinib -
- Primary Outcome Measures
Name Time Method Overall survival (OS) Expected to be 5.5 years after the first patient is enrollment.
- Secondary Outcome Measures
Name Time Method Objective response rate (ORR) evaluated by investigators based on RECIST v1.1 Expected to be 5.5 years after the first patient is enrollment. Duration of response (DoR) evaluated by blinded independent central review committee(BICR) based on Response Evaluation Criteria in Solid Tumors(RECIST) v1.1 Expected to be 5.5 years after the first patient is enrollment. Duration of response (DoR) evaluated by investigators based on Response Evaluation Criteria in Solid Tumors(RECIST) v1.1 Expected to be 5.5 years after the first patient is enrollment. Disease control rate (DCR) evaluated by blinded independent central review committee(BICR) based on Response Evaluation Criteria in Solid Tumors(RECIST) v1.1 Expected to be 5.5 years after the first patient is enrollment. Disease control rate (DCR) evaluated by investigators based on Response Evaluation Criteria in Solid Tumors(RECIST) v1.1 Expected to be 5.5 years after the first patient is enrollment. Percentage of Participants with Adverse Events Expected to be 5.5 years after the first patient is enrollment. Peak and trough serum concentrations of CS1003 Expected to be 5.5 years after the first patient is enrollment. Number and percentage of subjects who develop anti-CS1003 antibody (ADA) Expected to be 5.5 years after the first patient is enrollment. Objective response rate (ORR) assessed by blinded independent central review committee(BICR) Expected to be 5.5 years after the first patient is enrollment. Progression-free survival(PFS) evaluated by investigator based on RECIST v1.1 Expected to be 5.5 years after the first patient is enrollment. Progression-free survival(PFS) assessed by blinded independent central review committee(BICR) based on Response Evaluation Criteria in Solid Tumors(RECIST) v1.1 Expected to be 5.5 years after the first patient is enrollment. Time to deterioration (TTD), defined as the time from randomization to the first deterioration of European Organization for the Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) scale Expected to be 5.5 years after the first patient is enrollment.
Trial Locations
- Locations (74)
Nanfang Hospital
🇨🇳Guangzhou, Guangdong, China
Beijing You'an Hospital, Capital Medical University
🇨🇳Beijing, Beijing, 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
The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
🇨🇳Guangzhou, Guangdong, China
Guangxi Medical University Affiliated Tumor Hospital
🇨🇳Nanning, Guangxi, China
Harbin Medical University Cancer Hospital
🇨🇳Harbin, Heilongjiang, China
Luoyang Central Hospital
🇨🇳Luoyang, Henan, China
hubei Cancer Hospital
🇨🇳Wuhan, Hubei, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
Zhengzhou University - First Affiliated Hospital
🇨🇳Zhengzhou, Henan, 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
Yanbian University Hospital
🇨🇳Yanbian, Jilin, China
Jinan Military Region General Hospital of the People's Liber
🇨🇳Jinan, Shandong, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
Casa di Cura Dott. Pederzoli S.p.A (Ospedale Pederzoli)
🇮🇹Peschiera Del Garda, Verona, Italy
Centrum Badan Klinicznych
🇵🇱Wroclaw, Dolnoslaskie, Poland
Centrum Onkologii im. prof. F. Lukaszczyka
🇵🇱Bydgoszcz, Poland
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Asturias, Spain
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy
🇵🇱Warszawa, Poland
Chi Mei Medical Center - YongKang - Gastroenterology - Gastroenterology
🇨🇳Tainan, Taiwan
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Inland Empire Liver Foundation
🇺🇸Rialto, California, United States
Mercy Medical Center
🇺🇸Baltimore, Maryland, United States
The Second Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
The First Affiliated Hospital of Bengbu Medical College
🇨🇳Bengbu, Anhui, China
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital Of Anhui Medical University
🇨🇳Hefei, Anhui, China
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
Hainan General Hospital - Hepatology
🇨🇳Haikou, Hainan, China
The Second Affiliated Hospital of Soochow University
🇨🇳Suzhou, Jiangsu, China
The Second Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
Xuzhou Central Hospital
🇨🇳Xuzhou, Jiangsu, China
Shangdong Provicial Qianfoshan Hospital
🇨🇳Jinan, Shandong, China
Affiliated Hospital Of Jining Medical University
🇨🇳Jining, Shandong, China
The Affiliated Hospital of Qingdao University
🇨🇳Qingdao, Shandong, China
Linyi Cancer Hospital
🇨🇳Linyi, Shandong, China
Zhongshan Hospital, Fudan University
🇨🇳Shanghai, Shanghai, China
Shanghai Cancer Hospital of Fudan University
🇨🇳Shanghai, Shanghai, China
Shanghai Eastern Hepatobiliary Surgery Hospital - Hepatology
🇨🇳Shanghai, Shanghai, China
H.U. de Burgos
🇪🇸Burgos, Spain
Tianjin Medical University - Cancer Institute & Hospital - Oncology
🇨🇳Tianjin, Tianjin, China
Sichuan University - West China Hospital
🇨🇳Chengdu, Sichuan, China
Shanghai First People's Hospital
🇨🇳Shanghai, Shanghai, China
Azienda Unità Locale Socio Sanitaria n. 1 Dolomiti, Distretto di Feltre, Ospedale di Feltre
🇮🇹Feltre, Belluno, Italy
Fondazione IRCCS Policlinico San Matteo
🇮🇹Pavia, Italy
Istituto Oncologico Veneto IOV IRCCS - Medical Oncology Unit 1
🇮🇹Padova, Veneto, Italy
PO di Cremona, ASST di Cremona - Oncologia - Cremona - Radiology
🇮🇹Cremona, Italy
MED-POLONIA Sp.z o.o.
🇵🇱Poznan, Wielkopolskie, Poland
Complexo Hospitalario Universitario A Coruña
🇪🇸A Coruna, Galicia, Spain
Hospital Del Mar
🇪🇸Barcelona, Spain
Complejo Hospitalario Universitario de Orense
🇪🇸Ourense, Galicia, Spain
Hospital Ntra. Sra. de Sonsoles
🇪🇸Avila, Spain
ICO-Hospital Universitari de Girona Dr. Josep Trueta
🇪🇸Girona, Spain
Hospital Universitario Puerta De Hierro De Majadahonda
🇪🇸Majadahonda, Madrid, Spain
Hospital General Universitario Gregorio Marañón
🇪🇸Madrid, Spain
H.U.V.Arrixaca
🇪🇸Murcia, Spain
Hospital Universitario Virgen De La Macarena
🇪🇸Sevilla, 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
Tri-Service General Hospital - Neihu Branch - Pulmonary
🇨🇳Taipei, Taiwan
National Cheng Kung University Hospital - Internal Medicine
🇨🇳Tainan, Taiwan
Southern California Research Center
🇺🇸Coronado, California, United States
UMass Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
Stony Brook University Cancer Clinical Trials
🇺🇸Stony Brook, New York, United States