A Study to Evaluate SHR-1210 in Subjects With Advanced HCC

Phase 2

Completed

Brief Summary: This a randomized controlled Phase 2/3 study to evaluate the efficacy and safety of SHR-1210 in subjects with advanced HCC who failed or intolerable to prior systemic treatment. The primary study hypothesis is that SHR-1210 treatment improves Objective Response Rate and Overall Survival when compare with SOC.

Detailed Description: In June 2017, this study was revised to expand the Phase 2 part to enroll more subjects and remove the Phase 3 part under the same protocol. A Phase 3 study will be initiated separately.

Recruitment & Eligibility

Inclusion Criteria

Histologically confirmed HCC in advanced stage; not suitable to surgery or local regional treatment; with at least one measurable lesion per RECIST 1.1
Failed or intolerable to at least one prior systemic treatment for advanced HCC
ECOG Performance Status of 0 or1
Child-Pugh Class A or B with 7 points
Life Expectancy of at least 12 weeks
HBV DNA<500 IU/ml
Adequate organ function
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

Arm && Interventions

Group	Intervention	Description
SHR-1210 Q3W	SHR-1210	Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 3 weeks
SHR-1210 Q2W	SHR-1210	Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks

Primary Outcome Measures

Name	Time	Method
Objective Response Rate	approximate 3 years	Tumour responses were evaluated by the independent review committee (IRC) according to RECIST 1.1.The primary endpoints were the proportion of patients with a IRC-assessed objective response (defined as the percentage of patients whose best overall response was confirmed complete or partial response).
6-month Overall Survival Rate	from the date of the first dose to 6 months	6-month overall survival rate (defined as cumulative overall survival rate from the date of the first dose to 6 months)

Secondary Outcome Measures

Name	Time	Method
Adverse Events	approximate 3 years	Number of Subjects with one or more adverse events as assessed by CTCAE 4.03
Overall Survival	approximate 3 years	Time from first dose to death from any cause
Duration of Response	approximate 3 years	time from first response to progression or death base on the IRC assessment

Locations (17): Haerbin Medical University Cancer Hospital
🇨🇳
Haerbin, Heilongjiang, China
Zhangshan Hospital Fudan University
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Shanghai, Shanghai, China
Xiangya Hospital Central South University
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Changsha, Hunan, China
Fudan University Shanghai Cancer Center
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Shanghai, China
The First Affiliated Hospital of Bengbu Medical College
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Bengbu, Anhui, China
The Second Hospital of Anhui Medical University
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Hefei, Anhui, China
Cancer Hospital Chinese Academy of Medical Science
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Beijing, Beijing, China
Fujian Medical University Union Hospital
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Fuzhou, Fujian, China
Cancer Hospital of Shantou University Medical College
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Shantou, Guangdong, China
Guangdong General Hospital
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Guangzhou, Guangdong, China
Hunan Cancer Hospital
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Changsha, Hunan, China
Jilin Cancer Hospital
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Changchun, Jilin, China
81 Hospital Nanjing
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Nanjing, Jiangsu, China
The First Affiliated Hospital Zhejiang University
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Hangzhou, Zhejiang, China
The First Affiliated Hospital of Nanchang University
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Nanchang, Jiangxi, China
The First Affiliated Hospital of Xi'an Jiaotong University
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Xi'an, Shanxi, China
West China Hospital
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Chengdu, Sichuan, China