xml: <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/NCT06031480</url>
    </required_header>
    <id_info>
      <org_study_id>KY2023297</org_study_id>
      <nct_id>NCT06031480</nct_id>
    </id_info>
    <brief_title>Anlotinib and TQB2450 in Advanced Hepatocellular Carcinoma After Failure of Prior Immune Checkpoint Inhibitors</brief_title>
    <acronym>FAITH</acronym>
    <official_title>Study of Combination Treatment Using Anlotinib and TQB2450 in Patients With Advanced Hepatocellular Carcinoma Who Failed Prior Immune Checkpoint Inhibitor Therapies: a Single Arm, Multicenter Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shanghai Zhongshan Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Chia Tai Tianqing Pharmaceutical Group Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Shanghai Zhongshan Hospital</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 an multi-center, single arm, exploratory study to evaluate the efficacy and safety of&#xD;
        anlitinib combined with TQB2450 in patients with advanced hepatocellular carcinoma （HCC）who&#xD;
        failed prior immune checkpoint inhibitor therapies.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 31, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">October 31, 2025</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>Objective response rate (ORR, RECIST v1.1)</measure>
      <time_frame>24 months</time_frame>
      <description>ORR is defined as the proportion of subjects with complete response (CR) or partial response (PR) to study drugs</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">55</enrollment>
    <condition>Hepatocellular Carcinoma</condition>
    <arm_group>
      <arm_group_label>anlotinib+TQB2450</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Anlotinib and TQB2450</intervention_name>
      <description>Anlotinib: 10mg PO, QD, D1-14, Q3W; TQB2450: 1200 mg, IV, D1, Q3W.&#xD;
  Anlotinib and TQB2450 will be administered until the disease progression, intolerable toxicity, death, withdrawal of consent.</description>
      <arm_group_label>anlotinib+TQB2450</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  The participants must be required to sign an informed consent&#xD;
  &#xD;
            -  Hepatocellular carcinoma patients confirmed by pathological or cytological&#xD;
               examination, or who meet the clinical diagnostic criteria of the &quot;Guidelines for the&#xD;
               Diagnosis and Treatment of primary hepatocellular carcinoma&quot; (2022)&#xD;
  &#xD;
            -  At least one measurable lesion (RECIST 1.1)&#xD;
  &#xD;
            -  Chinese Liver Cancer Staging (CNLC): CNLC-IIa, IIb, IIIa, IIIb (BCLC-B and C) that are&#xD;
               not suitable for local treatment (TACE, HAIC, etc.) or that have progressed after&#xD;
               local treatment&#xD;
  &#xD;
            -  The previous treatment plan for patients before enrollment was a standard treatment&#xD;
               plan containing immune checkpoint inhibitors, and patients with progression or&#xD;
               intolerance were evaluated based on the RECIST v1.1 standard&#xD;
  &#xD;
            -  Child-Pugh Score, Class A or better B&#xD;
  &#xD;
            -  ECOG performance status 0 or 1&#xD;
  &#xD;
            -  Adequate organ function&#xD;
  &#xD;
            -  Life expectancy of at least 3 months&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who have received local treatment (including TACE, ablation, HAIC,&#xD;
               radiotherapy) and are less than 1 month after enrollment&#xD;
  &#xD;
            -  Patients who have received ≥ 2 treatments with immune checkpoint inhibitor regimens&#xD;
  &#xD;
            -  Adverse events above level 1(NCI-CTCAE v5.0) caused by any previous treatment that&#xD;
               have not returned to ≤ level 1 (excluding hair loss); Patients with previous severe&#xD;
               immune-related AEs requiring permanent cessation of immunotherapy&#xD;
  &#xD;
            -  Pregnant or lactating wome&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jia Fan</last_name>
      <role>Principal Investigator</role>
      <affiliation>Shanghai Zhongshan Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yinghao Shen</last_name>
      <phone>0086-13916276098</phone>
      <email>shen.yinghao@zs-hospital.sh.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Huichuan Sun</last_name>
      <phone>0086-13701922065</phone>
      <email>sun.huichuan@zs-hospital.sh.cn</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Zhongshan hospital</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>200032</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Yinghao Shen</last_name>
        <phone>+8613916276098</phone>
        <email>shen.yinghao@zs-hospital.sh.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>September 4, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</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>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06031480
  org study id: KY2023297
  nct id: NCT06031480
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  This is an multi-center, single arm, exploratory study to evaluate the efficacy and safety of
        anlitinib combined with TQB2450 in patients with advanced hepatocellular carcinoma （HCC）who
        failed prior immune checkpoint inhibitor therapies.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Objective response rate (ORR, RECIST v1.1)
  time frame: 24 months
  description: ORR is defined as the proportion of subjects with complete response (CR) or partial response (PR) to study drugs
  arm group label: anlotinib+TQB2450
  arm group type: Experimental
  intervention type: Drug
  intervention name: Anlotinib and TQB2450
  description: Anlotinib: 10mg PO, QD, D1-14, Q3W; TQB2450: 1200 mg, IV, D1, Q3W.
  Anlotinib and TQB2450 will be administered until the disease progression, intolerable toxicity, death, withdrawal of consent.
  arm group label: anlotinib+TQB2450
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Jia Fan
  role: Principal Investigator
  affiliation: Shanghai Zhongshan Hospital
  last name: Yinghao Shen
  phone: 0086-13916276098
  email: shen.yinghao@zs-hospital.sh.cn
  last name: Huichuan Sun
  phone: 0086-13701922065
  email: sun.huichuan@zs-hospital.sh.cn
  facility: 
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Carcinoma
  mesh term: Carcinoma, Hepatocellular