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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Controlled Multicentered Phase 2/3 Study to Evaluate SHR-1210 (PD-1 Antibody) in Subjects With Advanced Hepatocellular Carcinoma (HCC) Who Failed or Intolerable to Prior Systemic Treatment

Conditions
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Hepatocellular Carcinoma Non-Resectable

Intervention / Treatment
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* Biological: SHR-1210


Participation Criteria
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Eligibility Criteria
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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: Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC Known liver transplant or plan to transplant GI hemorrhage with 6 months History or current brain metastases Active known, or suspected autoimmune disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SHR-1210 Q2W<br>Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks | Biological: SHR-1210<br>* SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody<br>|
| Experimental: SHR-1210 Q3W<br>Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 3 weeks | Biological: SHR-1210<br>* SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate per RECIST 1.1 |  | Up to approximately 6 months | 
| Overall Survival Rate at 6-month |  | Up to approximately 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Response Rate per RECIST 1.1 |  | Up to approximately 2 years | 
| Number of Subjects with one or more adverse events as assessed by CTCAE 4.0 |  | Up to approximately 2 years | 
| Overall Survival |  | Up to approximately 2 years |