<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02989922</url>
  </required_header>
  <id_info>
    <org_study_id>SHR-1210-II/III-HCC</org_study_id>
    <nct_id>NCT02989922</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate SHR-1210 in Subjects With Advanced HCC</brief_title>
  <official_title>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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jiangsu HengRui Medicine Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jiangsu HengRui Medicine Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This a randomized controlled Phase 2/3 study to evaluate the efficacy and safety of SHR-1210&#xD;
      in subjects with advanced HCC who failed or intolerable to prior systemic treatment. The&#xD;
      primary study hypothesis is that SHR-1210 treatment improves Objective Response Rate and&#xD;
      Overall Survival when compare with SOC.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In June 2017, this study was revised to expand the Phase 2 part to enroll more subjects and&#xD;
      remove the Phase 3 part under the same protocol. A Phase 3 study will be initiated&#xD;
      separately.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Anticipated">June 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Objective Response Rate per RECIST 1.1</measure>
    <time_frame>Up to approximately 6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Survival Rate at 6-month</measure>
    <time_frame>Up to approximately 6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of Response Rate per RECIST 1.1</measure>
    <time_frame>Up to approximately 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects with one or more adverse events as assessed by CTCAE 4.0</measure>
    <time_frame>Up to approximately 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>Up to approximately 2 years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">220</enrollment>
  <condition>Hepatocellular Carcinoma Non-Resectable</condition>
  <arm_group>
    <arm_group_label>SHR-1210 Q2W</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SHR-1210 Q3W</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 3 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>SHR-1210</intervention_name>
    <description>SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody</description>
    <arm_group_label>SHR-1210 Q2W</arm_group_label>
    <arm_group_label>SHR-1210 Q3W</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Histologically confirmed HCC in advanced stage; not suitable to surgery or local&#xD;
             regional treatment; with at least one measurable lesion per RECIST 1.1&#xD;
&#xD;
          2. Failed or intolerable to at least one prior systemic treatment for advanced HCC&#xD;
&#xD;
          3. ECOG Performance Status of 0 or1&#xD;
&#xD;
          4. Child-Pugh Class A or B with 7 points&#xD;
&#xD;
          5. Life Expectancy of at least 12 weeks&#xD;
&#xD;
          6. HBV DNA&lt;500 IU/ml&#xD;
&#xD;
          7. Adequate organ function&#xD;
&#xD;
          8. Male or female participants of childbearing potential must be willing to use an&#xD;
             adequate method of contraception starting with the first dose of study drug through 60&#xD;
             days for female subjects and 120 days for male subjects after the last dose of study&#xD;
             drug&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC&#xD;
&#xD;
          2. Known liver transplant or plan to transplant&#xD;
&#xD;
          3. GI hemorrhage with 6 months&#xD;
&#xD;
          4. History or current brain metastases&#xD;
&#xD;
          5. Active known, or suspected autoimmune disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Bengbu Medical College</name>
      <address>
        <city>Bengbu</city>
        <state>Anhui</state>
        <zip>233004</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Hospital of Anhui Medical University</name>
      <address>
        <city>Hefei</city>
        <state>Anhui</state>
        <zip>230601</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Hospital Chinese Academy of Medical Science</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fujian Medical University Union Hospital</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <zip>350001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guangdong General Hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510080</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Hospital of Shantou University Medical College</name>
      <address>
        <city>Shantou</city>
        <state>Guangdong</state>
        <zip>515041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Haerbin Medical University Cancer Hospital</name>
      <address>
        <city>Haerbin</city>
        <state>Heilongjiang</state>
        <zip>150040</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xiangya Hospital Central South University</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410008</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hunan Cancer Hospital</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410013</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>81 Hospital Nanjing</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210002</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Nanchang University</name>
      <address>
        <city>Nanchang</city>
        <state>Jiangxi</state>
        <zip>330006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jilin Cancer Hospital</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <zip>130012</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhangshan Hospital Fudan University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Xi'an Jiaotong University</name>
      <address>
        <city>Xi'an</city>
        <state>Shanxi</state>
        <zip>710061</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West China Hospital</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital Zhejiang University</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fudan University Shanghai Cancer Center</name>
      <address>
        <city>Shanghai</city>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <last_update_submitted>December 24, 2017</last_update_submitted>
  <last_update_submitted_qc>December 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Hepatocellular</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>July 3, 2020</submitted>
    <returned>July 17, 2020</returned>
    <submitted>May 6, 2023</submitted>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02989922
org study id: SHR-1210-II/III-HCC
nct id: NCT02989922
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Objective Response Rate per RECIST 1.1
time frame: Up to approximately 6 months
measure: Overall Survival Rate at 6-month
time frame: Up to approximately 6 months
measure: Duration of Response Rate per RECIST 1.1
time frame: Up to approximately 2 years
measure: Number of Subjects with one or more adverse events as assessed by CTCAE 4.0
time frame: Up to approximately 2 years
measure: Overall Survival
time frame: Up to approximately 2 years
arm group label: SHR-1210 Q2W
arm group type: Experimental
description: Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks
arm group label: SHR-1210 Q3W
arm group type: Experimental
description: Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 3 weeks
intervention type: Biological
intervention name: SHR-1210
description: SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody
arm group label: SHR-1210 Q2W
arm group label: SHR-1210 Q3W
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
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country: China
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular
submitted: July 3, 2020
returned: July 17, 2020
submitted: May 6, 2023