A Study to Evaluate SHR-1210 in Combination With Apatinib as First-Line Therapy in Patients With Advanced HCC
NCT ID: NCT03764293
Last Updated: 2024-02-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
543 participants
INTERVENTIONAL
2019-06-10
2023-06-14
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
NONE
Study Groups
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SHR-1210
SHR-1210+Apatinib
SHR-1210
Subjects receive SHR-1210 intravenously, Dosage form: lyophilised powder, Strength: 200 mg /vial
Apatinib
Subjects receive Apatinib orally, Dosage form: tablet, Strength: 250 mg/tablet
Control
Sorafenib
Sorafenib
Subjects receive Sorafenib orally, Dosage form: tablet, Strength: 0.2 g/tablet
Interventions
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SHR-1210
Subjects receive SHR-1210 intravenously, Dosage form: lyophilised powder, Strength: 200 mg /vial
Apatinib
Subjects receive Apatinib orally, Dosage form: tablet, Strength: 250 mg/tablet
Sorafenib
Subjects receive Sorafenib orally, Dosage form: tablet, Strength: 0.2 g/tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No previous systematic treatment for HCC
* Have at least one measurable lesion (in accordance with RECIST v1.1)
* BCLC stage B or C, and not suitable for surgical or local therapy, or has progressed following surgical and/or local therapy
* ECOG-PS score 0 or 1
* Child-Pugh Class: Grade A
* Life Expectancy of at least 12 weeks
* Subjects with HBV infection: HBV DNA\<500 IU/ml or \< 2500 copy/mL, and have received anti-HBV therapy for at least 14 days prior to enrollment in the study
* Subjects with HCV-RNA(+) must receive antiviral therapy
* Adequate organ function
Exclusion Criteria
* Moderate-to-severe ascites with clinical symptoms
* History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal hemorrhage
* Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment
* Known genetic or acquired hemorrhage or thrombotic tendency
* Thrombosis or thromboembolic event within 6 months prior to the start of study treatment
* Cardiac clinical symptom or disease that is not well controlled
* Hypertension that can not be well controlled through antihypertensive drugs
* Factors to affect oral administration
* History of hepatic encephalopathy
* Previous or current presence of metastasis to central nervous system
* HIV infection
* Combined hepatitis B and hepatitis C co-infection
* Be ready for or previously received organ or allogenic bone marrow transplantation
* Interstitial lung disease that is symptomatic or may interfere with the detection and management of suspected drug-related pulmonary toxicity
* Active known, or suspected autoimmune disease
* Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of first administration of study treatment
* Use of potent CYP3A4 inducers or inhibitors within 2 weeks prior to the signature of ICF
* Known history of serious allergy to any monoclonal antibody or targeted anti-angiogenic drug
* Severe infection within 4 weeks prior to the start of study treatment
* Palliative radiotherapy for non-target lesions to control symptoms is allowed, but it must be completed at least 2 weeks prior to the start of study treatment
* Treatment of other investigational product(s) within 28 days prior to the start of study treatment
18 Years
ALL
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Shukui Qin, MD
Role: PRINCIPAL_INVESTIGATOR
Eastern Theater General Hospital,QinHuai District Medical Area
Locations
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Beverly Hills Cancer Center
Beverly Hills, California, United States
University of California San Diego (UCSD)-Moores Cancer Center
La Jolla, California, United States
University of California - Irvine
Orange, California, United States
University of Maryland
Baltimore, Maryland, United States
Cornell University Weill Cornell Medical College
New York, New York, United States
The Center for Cancer and Blood Disorders
Fort Worth, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Renovatio Clinical
The Woodlands, Texas, United States
Cliniques Universitaires de Bruxelles Hopital Erasme
Brussels, , Belgium
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
UZA
Edegem, , Belgium
AZ Maria Middelares
Ghent, , Belgium
AZ Groeninge
Kortrijk, , Belgium
Anhui Provincal Cancer Hospital
Hefei, Anhui, China
Anhui Provincal Hospital
Hefei, Anhui, China
The First Affiliated Hospital Of Anhui Medical University
Hefei, Anhui, China
The Second Affiliated Hospital Of Anhui Medical University
Hefei, Anhui, China
Chinese Academy of Medical Sciences Cancer Hospital
Beijing, Beijing Municipality, China
Beijing cancer Hospital
Beijing, Beijing Municipality, China
Peking University International Hospital
Beijing, Beijing Municipality, China
The Second Hospital Affiliated To AMU
Chongqing, Chongqing Municipality, China
The First Hospital Affiliated To AMU
Chongqing, Chongqing Municipality, China
TheThird Affiliated Hospital ,Army Medical University
Chongqing, Chongqing Municipality, China
The Second Affiliated Hospital of ChongQing Medical University
Chongqing, Chongqing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
The 940th Hospital of the joint logistic support force of People's Liberation Army
Lanzhou, Gansu, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
NanFang Hospital of Southern Medical University
Guangzhou, Guangdong, China
The first affiliated hospital of guangxi medical university
Nanning, Guangxi, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Wuhan Union Hospital,Tongji Medical College,Huazhong University of Science&Technology
Wuhan, Hubei, China
Tongji hospital,Tongji Medical College,Huazhong University of Science&Technology
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
Eastern Theater General Hospital, Qinhuai District Medical Area
Nanjing, Jiangsu, China
The First Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi, China
Jilin Cancer Hospital
Changchun, Jilin, China
The First Hospital of Jilin University
Changchun, Jilin, China
The Sixth People's Hospital of Shengyang
Shengyang, Liaoning, China
Liaoning Cancer Hospital
Shenyang, Liaoning, China
Shandong Cancer Hospital Affiliated to Shandong University
Jinan, Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Sichuan Cancer Hospital&Institute
Chengdu, Sichuan, China
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China
ZheJiang Cancer Hospital
Hangzhou, Zhejiang, China
The First Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang, China
Charite Universitaetsmedizin Berlin - Campus Virchow-Klinikum Berlin
Berlin, , Germany
Pamela Youde Nethersole Eastern Hospital
Hong Kong, , Hong Kong
The University of Hong Kong
Hong Kong, , Hong Kong
Tuen Mun Hospital
Hong Kong, , Hong Kong
The Chinese University of Hong Kong
Shatin, , Hong Kong
A.S.L. Napoli 1 Centro Ospedale del Mare
Ponticelli, Napoli, Italy
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
Bologna, , Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
Brescia, , Italy
Azienda Ospedaliero-Universitaria
Cagliari, , Italy
Azienda Ospedaliera Universitaria Careggi
Florence, , Italy
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Milan, , Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, , Italy
Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma)
Verona, , Italy
Centrum Medyczne Pratia Gdynia
Gdynia, , Poland
Centrum Onkologii-Instytut im.M.Sklodowskiej Curie
Gliwice, , Poland
Pratia MCM Krakow
Krakow, , Poland
Przychodnia Med-Polonia Sp. z o.o.
Poznan, , Poland
Wielkopolskie Centrum Onkologii
Poznan, , Poland
Centrum Zdrowia MDM
Warsaw, , Poland
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy
Warsaw, , Poland
NZOZ Centrum Badan Klinicznych
Wroclaw, , Poland
SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary"
Arkhangelsk, , Russia
SBHI Chelyabinsk Regional Clinical Center for Oncology and Nuclear Medicine
Chelyabinsk, , Russia
Irkutsk Regional Oncology Dispensary
Irkutsk, , Russia
SBIH " Clinical Oncological Dispensary # 1"
Krasnodar, , Russia
RBIH "Kursk regional clinical oncology dispensary" of Kursk Region Healthcare Committee
Kursk, , Russia
"VitaMed" LLC
Moscow, , Russia
SBIH of Moscow city "Moscow city oncology hospital №62" of Moscow Healthcare departement
Moscow, , Russia
CJSC Avicenna
Novosibirsk, , Russia
BHI of Omsk region "Clinical Oncology Dispensary"
Omsk, , Russia
Pavlov First Saint Petersburg State Medical University
Saint Petersburg, , Russia
SPb SBIH "City Clinical Oncological Dispensary"
Saint Petersburg, , Russia
FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"
Saint Petersburg, , Russia
SBIH Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan
Ufa, , Russia
Seoul National University Bundang Hospital Gyeonggi-do
Seongnam-si, Gyeonggi-do, South Korea
The Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do, South Korea
Ajou University Hospital
Suwon, Gyeonggi-do, South Korea
Dong-A University Hospital
Busan, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hospital Universitario Reina Sofia
Córdoba, Córdoba, Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Universitario Clinico San Carlos
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario HM Madrid Sanchinarro
Madrid, , Spain
Hospital Universitari i Politecnic La Fe
Valencia, , Spain
Changhua Christian Medical Foundation Changhua Christian Hospital
Changhua, , Taiwan
Chang Gung Memorial Hospital, Chiayi
Chiayi City, , Taiwan
E-DA Cancer Hospital
Kaohsiung City, , Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan District, , Taiwan
Baskent University Adana Application and Research Center
Adana, , Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital
Ankara, , Turkey (Türkiye)
Ankara City Hospital
Ankara, , Turkey (Türkiye)
Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
Istanbul, , Turkey (Türkiye)
Bakirkoy Dr. Sadi Konuk Teaching and Research Hospital
Istanbul, , Turkey (Türkiye)
Inonu Uni. Med. Fac.
Malatya, , Turkey (Türkiye)
CNE"City Clin Hosp#4"of Dnipro City Council Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU
Dnipro, , Ukraine
Communal Non-profit Enterprise Regional Center of Oncology
Kharkiv, , Ukraine
CI of Healthcare Regional Clinical Specialized Dispensary of the Radiation Protection
Kharkiv, , Ukraine
Medical Center of Limited Liability Company Medical Center Concilium Medical
Kyiv, , Ukraine
Communal Enterprise Volyn Regional Medical Center of Oncology of Volyn Regional Council
Lutsk, , Ukraine
Communal Institution Odesa Regional Clinical Hospital
Odesa, , Ukraine
CNCE of SRC Sumy Reg Clinical Oncology Dispensary, SSU, Chair of Oncology and Radiology
Sumy, , Ukraine
Zaporizhzhya City Clinical Hospital #3
Zaporizhzhia, , Ukraine
Countries
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References
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Qin S, Chan SL, Gu S, Bai Y, Ren Z, Lin X, Chen Z, Jia W, Jin Y, Guo Y, Hu X, Meng Z, Liang J, Cheng Y, Xiong J, Ren H, Yang F, Li W, Chen Y, Zeng Y, Sultanbaev A, Pazgan-Simon M, Pisetska M, Melisi D, Ponomarenko D, Osypchuk Y, Sinielnikov I, Yang TS, Liang X, Chen C, Wang L, Cheng AL, Kaseb A, Vogel A; CARES-310 Study Group. Camrelizumab plus rivoceranib versus sorafenib as first-line therapy for unresectable hepatocellular carcinoma (CARES-310): a randomised, open-label, international phase 3 study. Lancet. 2023 Sep 30;402(10408):1133-1146. doi: 10.1016/S0140-6736(23)00961-3. Epub 2023 Jul 24.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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SHR-1210-III-310
Identifier Type: -
Identifier Source: org_study_id
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