<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/NCT04487704</url>
  </required_header>
  <id_info>
    <org_study_id>XJYFY-KRLZ-HCC-1</org_study_id>
    <nct_id>NCT04487704</nct_id>
  </id_info>
  <brief_title>Camrelizumab Utilization on Patients With Advanced Liver Cancer</brief_title>
  <official_title>A Real World Study of Treatment Regimens Containing Camrelizumab in Patients With Advanced Liver Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>First Affiliated Hospital Xi'an Jiaotong University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>First Affiliated Hospital Xi'an Jiaotong University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To observe and evaluate the safety and efficacy of camrelizumab in advanced liver cancer&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      camrelizumab ， a humanized monoclonal antibody against PD-1, has been shown to block the&#xD;
      binding of PD-1 to PD-L1, thereby inhibiting the immune escape of tumor cells. It has a high&#xD;
      affinity for PD-1 (KD = 3.31 nmol/L), a high acceptor proportion (85% at 200 mg) of&#xD;
      circulating T lymphocytes, and binds to epitopes different from Nivolumab and&#xD;
      pembrolizumab，Phase 1 clinical trials have shown that camrelizumab is well tolerated and has&#xD;
      antitumor activity in patients with advanced solid tumors.camrelizumab has been approved for&#xD;
      indication for advanced hepatocellular carcinoma The main objective of this study was to&#xD;
      observe and evaluate the safety and efficacy of treatment regiments containing Camrelizumab&#xD;
      in advanced liver cancer。 The subjects included people over 18 years old， For men and women&#xD;
      with advanced liver cancer confirmed by histopathology or cytology;&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 7, 2020</start_date>
  <completion_date type="Anticipated">January 2025</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2023</primary_completion_date>
  <phase>N/A</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>Assess Safety as defined by the NCI CTCAE v5.0</measure>
    <time_frame>From patients participate in the clinical study to 90 days after the end of treatment</time_frame>
    <description>Adverse events as graded by CTCAE v5.0</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>overall survival</measure>
    <time_frame>5 years</time_frame>
    <description>1-year, 3-year, 5-year survival</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Advanced Hepatocellular Carcinoma</condition>
  <arm_group>
    <arm_group_label>Camrelizumab in the treatment of liver cancer</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Camrelizumab intravenous infusion (no need for prophylactic administration), no less than 30 min</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>camrelizumab</intervention_name>
    <description>camrelizumab 200 mg, intravenous infusion (no need for prophylactic administration), no less than 30 min ，No more than 60 min, one cycle every 2 weeks (14 days) or one cycle every 3 weeks (21 days). Try to complete the administration before the ECG</description>
    <arm_group_label>Camrelizumab in the treatment of liver cancer</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years old or more;&#xD;
&#xD;
          -  For both men and women;&#xD;
&#xD;
          -  Patients with advanced liver cancer confirmed by histopathology or cytology;&#xD;
             .Volunteer to join the study, sign the informed consent, good compliance, and&#xD;
             cooperate with the follow-up.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A known allergy to the study drug or any of its excipients; Or had a severe allergic&#xD;
             reaction to other monoclonal antibodies;&#xD;
&#xD;
          -  Patients who are ready for or have previously received an organ or allogeneic bone&#xD;
             marrow transplant;&#xD;
&#xD;
          -  Pregnant or lactating women;&#xD;
&#xD;
          -  According to the judgment of the researcher, the patients should not be included in&#xD;
             this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yi Lyu, MD,phD</last_name>
    <role>Principal Investigator</role>
    <affiliation>First Affiliated Hospital Xi'an Jiaotong University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xu-Feng Zhang, MD,phD</last_name>
    <phone>86-029-13359260373</phone>
    <email>xfzhang125@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Rui Qu</last_name>
    <phone>86-18681943306</phone>
    <email>1289271841@qq.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>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>
    <status>Recruiting</status>
    <contact>
      <last_name>Yi Lv, MD,PHD</last_name>
      <phone>0086-13991200581</phone>
      <email>luyi169@126.com</email>
    </contact>
    <contact_backup>
      <last_name>Xiaogang Zhang, Phd</last_name>
      <phone>0086-13891803523</phone>
      <email>zzsghr@qq.com</email>
    </contact_backup>
    <investigator>
      <last_name>Yi Lv, MD,PHD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>April 27, 2022</last_update_submitted>
  <last_update_submitted_qc>April 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>RWS</keyword>
  <keyword>Advanced Liver Cancer</keyword>
  <keyword>PD-1</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Neoplasms</mesh_term>
  </condition_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/NCT04487704
org study id: XJYFY-KRLZ-HCC-1
nct id: NCT04487704
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
To observe and evaluate the safety and efficacy of camrelizumab in advanced liver cancer
camrelizumab ， a humanized monoclonal antibody against PD-1, has been shown to block the
      binding of PD-1 to PD-L1, thereby inhibiting the immune escape of tumor cells. It has a high
      affinity for PD-1 (KD = 3.31 nmol/L), a high acceptor proportion (85% at 200 mg) of
      circulating T lymphocytes, and binds to epitopes different from Nivolumab and
      pembrolizumab，Phase 1 clinical trials have shown that camrelizumab is well tolerated and has
      antitumor activity in patients with advanced solid tumors.camrelizumab has been approved for
      indication for advanced hepatocellular carcinoma The main objective of this study was to
      observe and evaluate the safety and efficacy of treatment regiments containing Camrelizumab
      in advanced liver cancer。 The subjects included people over 18 years old， For men and women
      with advanced liver cancer confirmed by histopathology or cytology;
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Assess Safety as defined by the NCI CTCAE v5.0
time frame: From patients participate in the clinical study to 90 days after the end of treatment
description: Adverse events as graded by CTCAE v5.0
measure: overall survival
time frame: 5 years
description: 1-year, 3-year, 5-year survival
arm group label: Camrelizumab in the treatment of liver cancer
arm group type: Other
description: Camrelizumab intravenous infusion (no need for prophylactic administration), no less than 30 min
intervention type: Other
intervention name: camrelizumab
description: camrelizumab 200 mg, intravenous infusion (no need for prophylactic administration), no less than 30 min ，No more than 60 min, one cycle every 2 weeks (14 days) or one cycle every 3 weeks (21 days). Try to complete the administration before the ECG
arm group label: Camrelizumab in the treatment of liver cancer
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yi Lyu, MD,phD
role: Principal Investigator
affiliation: First Affiliated Hospital Xi'an Jiaotong University
last name: Xu-Feng Zhang, MD,phD
phone: 86-029-13359260373
email: xfzhang125@126.com
last name: Rui Qu
phone: 86-18681943306
email: 1289271841@qq.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: China
responsible party type: Sponsor
mesh term: Liver Neoplasms