A Study to Evaluate SHR-1210 in Subjects With Advanced HCC
NCT ID: NCT02989922
Last Updated: 2024-03-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
220 participants
INTERVENTIONAL
2016-11-15
2020-03-03
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 Q2W
Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks
SHR-1210
SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody
SHR-1210 Q3W
Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 3 weeks
SHR-1210
SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody
Interventions
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SHR-1210
SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody
Eligibility Criteria
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Inclusion Criteria
2. Failed or intolerable to at least one prior systemic treatment for advanced HCC
3. ECOG Performance Status of 0 or1
4. Child-Pugh Class A or B with 7 points
5. Life Expectancy of at least 12 weeks
6. HBV DNA\<500 IU/ml
7. Adequate organ function
8. Male or female participants of childbearing potential must be willing to use an adequate method of contraception starting with the first dose of study drug through 60 days for female subjects and 120 days for male subjects after the last dose of study drug
Exclusion Criteria
2. Known liver transplant or plan to transplant
3. GI hemorrhage with 6 months
4. History or current brain metastases
5. Active known, or suspected autoimmune disease
18 Years
ALL
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Guangdong General Hospital
Guangzhou, Guangdong, China
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, China
Haerbin Medical University Cancer Hospital
Haerbin, Heilongjiang, China
Xiangya Hospital Central South University
Changsha, Hunan, China
Hunan Cancer Hospital
Changsha, Hunan, China
81 Hospital Nanjing
Nanjing, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Jilin Cancer Hospital
Changchun, Jilin, China
Zhangshan Hospital Fudan University
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
West China Hospital
Chengdu, Sichuan, China
The First Affiliated Hospital Zhejiang University
Hangzhou, Zhejiang, China
Fudan University Shanghai Cancer Center
Shanghai, , China
Countries
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References
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Zhou X, Cao J, Topatana W, Xie T, Chen T, Hu J, Li S, Juengpanic S, Lu Z, Zhang B, Wang K, Feng X, Shen J, Chen M. Evaluation of PD-L1 as a biomarker for immunotherapy for hepatocellular carcinoma: systematic review and meta-analysis. Immunotherapy. 2023 Apr;15(5):353-365. doi: 10.2217/imt-2022-0168. Epub 2023 Feb 27.
Shi J, Liu J, Tu X, Li B, Tong Z, Wang T, Zheng Y, Shi H, Zeng X, Chen W, Yin W, Fang W. Single-cell immune signature for detecting early-stage HCC and early assessing anti-PD-1 immunotherapy efficacy. J Immunother Cancer. 2022 Jan;10(1):e003133. doi: 10.1136/jitc-2021-003133.
Qin S, Ren Z, Meng Z, Chen Z, Chai X, Xiong J, Bai Y, Yang L, Zhu H, Fang W, Lin X, Chen X, Li E, Wang L, Chen C, Zou J. Camrelizumab in patients with previously treated advanced hepatocellular carcinoma: a multicentre, open-label, parallel-group, randomised, phase 2 trial. Lancet Oncol. 2020 Apr;21(4):571-580. doi: 10.1016/S1470-2045(20)30011-5. Epub 2020 Feb 26.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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SHR-1210-II/III-HCC
Identifier Type: -
Identifier Source: org_study_id
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