<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/NCT03793725</url>
  </required_header>
  <id_info>
    <org_study_id>HZ-T-PD1-APA</org_study_id>
    <nct_id>NCT03793725</nct_id>
  </id_info>
  <brief_title>A Trial of SHR-1210 in Combination With Apatinib in Patients With Unresectable HCC</brief_title>
  <acronym>HZ-T-PD1-APA</acronym>
  <official_title>A Phase II , Open-label , Investigator-initiated Trail of An Anti-PD-1 Inhibitor SHR-1210 in Combination With Apatinib in Patients With Unresectable Hepatocellular Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yanqiao Zhang</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Jiangsu HengRui Medicine Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Harbin Medical University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase II , Open-label , Investigator-initiated Trail of SHR-1210 (an Anti-PD-1&#xD;
      Inhibitor) in Combination With Apatinib in Patients With unresectable Hepatocellular&#xD;
      Carcinoma.&#xD;
&#xD;
      This study aims to evaluate the safety and efficacy of SHR-1210 combination with Apatinib as&#xD;
      a preoperative treatment of unresectable HCC.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 30, 2019</start_date>
  <completion_date type="Anticipated">January 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">January 30, 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>R0 (resection rate)</measure>
    <time_frame>1 week after surgery</time_frame>
    <description>R0 resection rate</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ORR</measure>
    <time_frame>from the first drug administration up to one year</time_frame>
    <description>Objective Response Rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>RFS</measure>
    <time_frame>from the first drug administration up to one year</time_frame>
    <description>relapse free survival</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Hepatocellular Carcinoma</condition>
  <arm_group>
    <arm_group_label>SHR-1210 + Apatinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug: SHR-1210 SHR-1210 was administered 200mg iv every 2 weeks Drug: Apatinib Apatinib was administered 500mg oral daily during the first 2 weeks and then 250 mg qd</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SHR1210</intervention_name>
    <description>Anti-PD-1 Antibody</description>
    <arm_group_label>SHR-1210 + Apatinib</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Apatinib</intervention_name>
    <description>Anti-angiogenic drugs</description>
    <arm_group_label>SHR-1210 + Apatinib</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects voluntarily participate in this study and sign informed consent .&#xD;
&#xD;
          -  Men or women aged 18-75 years&#xD;
&#xD;
          -  patients with Unresectable HCC confirmed histologically or cytologically or&#xD;
             clinically，At least one measurable lesion that meets the RECIST v1.1 criteria without&#xD;
             local treatment.&#xD;
&#xD;
          -  The patients can swallow pills normally.&#xD;
&#xD;
          -  ECOG score was 0 or 1.&#xD;
&#xD;
          -  Have a life expectancy of at least 12 weeks.&#xD;
&#xD;
          -  The functions of vital organs meet the following requirements (excluding the use of&#xD;
             any blood components and cytokines during screening) : Neutrophils≥1.5 x 109/L,&#xD;
             Hb≥9g/dL; Plt≥90 x 109/L, ALB≥3g/dL, TSH≤ULN(Upper Limit Of Norma), TBIL ≤ 1.25 x ULN,&#xD;
             ALT and AST ≤ 1.5 x ULN, AKP≤ 2.5 x ULN, CR≤ 1.5 x ULN&#xD;
&#xD;
          -  Female Subjects of childbearing potential must have a negative serum pregnancy test&#xD;
             within 72 hours before the first dose and must be willing to use very efficient&#xD;
             barrier methods of contraception for the course of the study through 3 months after&#xD;
             the last dose of study treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects had any active autoimmune disease or history of autoimmune disease.&#xD;
&#xD;
          -  Subjects are using immunosuppressive agents, or systemic, or absorptive,local hormone&#xD;
             therapy to achieve immunosuppression. It is still in use within 2 weeks before&#xD;
             enrollment.&#xD;
&#xD;
          -  Subjects with severe allergic reactions to other monoclonal antibodies.&#xD;
&#xD;
          -  The subjects had a central nervous system metastases of clinical symptoms.&#xD;
&#xD;
          -  A heart condition or disease that is not well controlled.&#xD;
&#xD;
          -  Subjects had active infections.&#xD;
&#xD;
          -  Other clinical trials of drugs were used within 4 weeks prior to the first&#xD;
             administration.&#xD;
&#xD;
          -  The subjects have received other PD-1 antibody therapy or other immunotherapy for PD-1&#xD;
             / PD-L1 or CDK4/6 inhibitor treatment in the past.&#xD;
&#xD;
          -  There are other factors lead to patients can not participate in this clinical study by&#xD;
             the judgment of the investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zhang Yanqiao, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Study Principal Investigator Harbin Medical University Cancer Hosptital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zhang Yanqiao, PHD</last_name>
    <phone>138 4512 0210</phone>
    <email>yanqiaozhang@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Wang Guangyu, PHD</last_name>
    <phone>18249038966</phone>
    <email>18249038966@163.com</email>
  </overall_contact_backup>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>January 3, 2019</last_update_submitted>
  <last_update_submitted_qc>January 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Harbin Medical University</investigator_affiliation>
    <investigator_full_name>Yanqiao Zhang</investigator_full_name>
    <investigator_title>Director of the hospital</investigator_title>
  </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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Apatinib</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03793725
org study id: HZ-T-PD1-APA
nct id: NCT03793725
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This is a Phase II , Open-label , Investigator-initiated Trail of SHR-1210 (an Anti-PD-1
      Inhibitor) in Combination With Apatinib in Patients With unresectable Hepatocellular
      Carcinoma.

      This study aims to evaluate the safety and efficacy of SHR-1210 combination with Apatinib as
      a preoperative treatment of unresectable HCC.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: R0 (resection rate)
time frame: 1 week after surgery
description: R0 resection rate
measure: ORR
time frame: from the first drug administration up to one year
description: Objective Response Rate
measure: RFS
time frame: from the first drug administration up to one year
description: relapse free survival
arm group label: SHR-1210 + Apatinib
arm group type: Experimental
description: Drug: SHR-1210 SHR-1210 was administered 200mg iv every 2 weeks Drug: Apatinib Apatinib was administered 500mg oral daily during the first 2 weeks and then 250 mg qd
intervention type: Drug
intervention name: SHR1210
description: Anti-PD-1 Antibody
arm group label: SHR-1210 + Apatinib
intervention type: Drug
intervention name: Apatinib
description: Anti-angiogenic drugs
arm group label: SHR-1210 + Apatinib
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Zhang Yanqiao, PHD
role: Principal Investigator
affiliation: Study Principal Investigator Harbin Medical University Cancer Hosptital
last name: Zhang Yanqiao, PHD
phone: 138 4512 0210
email: yanqiaozhang@126.com
last name: Wang Guangyu, PHD
phone: 18249038966
email: 18249038966@163.com
responsible party type: Sponsor-Investigator
investigator affiliation: Harbin Medical University
investigator full name: Yanqiao Zhang
investigator title: Director of the hospital
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular
mesh term: Apatinib