<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/NCT04428437</url>
  </required_header>
  <id_info>
    <org_study_id>VICI-6</org_study_id>
    <nct_id>NCT04428437</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Lenvatinib in Subjects With HCC Progression After First Line Treatment With Checkpoint Inhibitors</brief_title>
  <official_title>An Observational Study to Evaluate the Safety and Efficacy of Lenvatinib in HCC Subjects Who Have Progressive Disease After First Line Treatment With Checkpoint Inhibitors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Humanity &amp; Health Medical Group Limited</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Beijing 302 Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kindai University Faculty of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Humanity &amp; Health Medical Group Limited</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to evaluate the efficacy of lenvatinib in HCC subjects who&#xD;
      have progressive disease after first line treatment with checkpoint inhibitors.&#xD;
&#xD;
      Approximately 20 subjects will be enrollment to evaluate the efficacy and safety of&#xD;
      lenvatinib.&#xD;
&#xD;
      CT/MRI assessments will be made at end of first line treatment with checkpoint inhibitors,&#xD;
      and every 8-12 weeks thereafter. Disease status will be determined at the site (ie.&#xD;
      Investigator and/or radiologist) using RECIST version 1.1.&#xD;
&#xD;
      The primary efficacy endpoint is response rate (RR) defined as proportion of subjects with&#xD;
      SD/PR/CR per RECIST 1.1.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 2022</start_date>
  <completion_date type="Anticipated">February 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Response rate (RR)</measure>
    <time_frame>12 month</time_frame>
    <description>It is the sum of the proportion of stable disease (SD), complete response (CR) and partial response(PR) per RECIST 1.1. That is, RR = SD + CR + PR</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>12 month</time_frame>
    <description>An adverse event (AE) refers to any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, but which does not necessarily have a causal relationship with this treatment. Number and classification of participants with treatment-related adverse events as assessed by CTCAE v4.0 were recorded.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Hepatocellular Carcinoma</condition>
  <arm_group>
    <arm_group_label>Lenvatinib</arm_group_label>
    <description>Subjects with HCC progression after first line treatment with checkpoint inhibitors will get the treatment by lenvatinib.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-Lenvatinib</arm_group_label>
    <description>Subjects with HCC progression after first line treatment with checkpoint inhibitors will get the treatment by non-lenvatinib.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lenvatinib</intervention_name>
    <description>Prescribed by physician.</description>
    <arm_group_label>Lenvatinib</arm_group_label>
    <other_name>Lenvima</other_name>
    <other_name>E7080</other_name>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      A blood sample for alpha-fetoprotein (AFP) assessment will be obtained by local laboratory&#xD;
      every 4 weeks to correlate with each radiographic disease assessment visit.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects with HCC progression after first line treatment with checkpoint inhibitors&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥ 18 years old on the day of consent&#xD;
&#xD;
          2. Capable of understanding and complying with the protocol requirements and signed&#xD;
             informed consent&#xD;
&#xD;
          3. Documented histological or cytological diagnosis of HCC&#xD;
&#xD;
          4. HCC progression after first line treatment with checkpoint inhibitors per RECIST 1.1&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma&#xD;
&#xD;
          2. Prior TKI treatment&#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>Humanity &amp; Health Clinical Trial Centre</name>
      <address>
        <city>Hong Kong</city>
        <state>Hong Kong SAR</state>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>August 27, 2021</last_update_submitted>
  <last_update_submitted_qc>August 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2021</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, Hepatocellular</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lenvatinib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04428437
org study id: VICI-6
nct id: NCT04428437
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to evaluate the efficacy of lenvatinib in HCC subjects who
      have progressive disease after first line treatment with checkpoint inhibitors.

      Approximately 20 subjects will be enrollment to evaluate the efficacy and safety of
      lenvatinib.

      CT/MRI assessments will be made at end of first line treatment with checkpoint inhibitors,
      and every 8-12 weeks thereafter. Disease status will be determined at the site (ie.
      Investigator and/or radiologist) using RECIST version 1.1.

      The primary efficacy endpoint is response rate (RR) defined as proportion of subjects with
      SD/PR/CR per RECIST 1.1.
observational model: Cohort
time perspective: Prospective
measure: Response rate (RR)
time frame: 12 month
description: It is the sum of the proportion of stable disease (SD), complete response (CR) and partial response(PR) per RECIST 1.1. That is, RR = SD + CR + PR
measure: Adverse Events
time frame: 12 month
description: An adverse event (AE) refers to any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, but which does not necessarily have a causal relationship with this treatment. Number and classification of participants with treatment-related adverse events as assessed by CTCAE v4.0 were recorded.
arm group label: Lenvatinib
description: Subjects with HCC progression after first line treatment with checkpoint inhibitors will get the treatment by lenvatinib.
arm group label: Non-Lenvatinib
description: Subjects with HCC progression after first line treatment with checkpoint inhibitors will get the treatment by non-lenvatinib.
intervention type: Drug
intervention name: Lenvatinib
description: Prescribed by physician.
arm group label: Lenvatinib
other name: Lenvima
other name: E7080
A blood sample for alpha-fetoprotein (AFP) assessment will be obtained by local laboratory
      every 4 weeks to correlate with each radiographic disease assessment visit.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Hong Kong
responsible party type: Sponsor
mesh term: Carcinoma, Hepatocellular
mesh term: Lenvatinib
sharing ipd: No