<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/NCT04490694</url>
  </required_header>
  <id_info>
    <org_study_id>B2019-151R</org_study_id>
    <nct_id>NCT04490694</nct_id>
  </id_info>
  <brief_title>TACE Combined With Lenvatinib for Unresectable Hepatocellular Carcinoma</brief_title>
  <official_title>TACE Combined With Lenvatinib for Unresectable Hepatocellular Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Zhongshan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Zhongshan Hospital</source>
  <oversight_info>
    <has_dmc>No</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>
      It is an exploratory clinical study aimed to evaluate the efficacy and safety of TACE&#xD;
      combined with Lenvatinib in the treatment of patients with BCLC stage B and C HCC.Treatment&#xD;
      will continue until the death or intolerable toxicity or patients withdrawal of consent,and&#xD;
      the target sample size is 54 individuals.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, single-center and single-arm exploratory clinical study designed to&#xD;
      evaluate the efficacy and safety of TACE combined with Lenvatinib in the treatment of&#xD;
      patients with BCLC stage B and C hepatocellular carcinoma.Treatment will continue until the&#xD;
      death or intolerable toxicity or patients withdrawal of consent,and the target sample size is&#xD;
      54 individuals.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">March 1, 2020</start_date>
  <completion_date type="Anticipated">August 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2022</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>Time to progression（TTP）</measure>
    <time_frame>2 years</time_frame>
    <description>The time from the beginning of randomization to the tumor progression of the patient</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Objective remission rate（ORR）</measure>
    <time_frame>2 years</time_frame>
    <description>ORR according to modified RECIST for Hepatocellular Carcinoma</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>2 years</time_frame>
    <description>Adverse event (AE)、Treatment emergent adverse event(TEAE)、Serious adverse event (SAE)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>5 years</time_frame>
    <description>the survival time after randomization</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">54</enrollment>
  <condition>Hepatocellular Carcinoma</condition>
  <arm_group>
    <arm_group_label>TACE Combined with Lenvatinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lenvatinib</intervention_name>
    <description>Intervention Description：lenvatinib will be administered daily (for patients &lt;60kg, lenvatinib 8mg bid po for patients ≥60kg, lenvatinib 12mg bid po) until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.</description>
    <arm_group_label>TACE Combined with Lenvatinib</arm_group_label>
    <other_name>Lenvatinib treatment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>TACE</intervention_name>
    <description>Patients will be treated with TACE 2-4 weeks after randomization: the blood supply of the tumor will be evaluated by transradial / femoral artery approach, microcatheter will be inserted into the tumor feeding artery, and lipiodol plus epirubicin emulsifier will be injected (40mg epirubicin will be added to each 10ml lipiodol, the total amount should less than 20ml, epirubicin 40-60mg). Gelatin sponge particles / microspheres are used to strengthen embolization. Blood biochemical examination will be performed within 1 week before TACE, 3 days after operation and 1 month after operation.</description>
    <arm_group_label>TACE Combined with Lenvatinib</arm_group_label>
    <other_name>Transcatheter arterial chemoembolization</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - 1. Histopathologically or clinically confirmed unresectable hepatocellular carcinoma.&#xD;
&#xD;
        2. Age ≥ 18 years at time of study entry. 3. Child-Pugh scores &lt;7. 4. Performance status&#xD;
        (PS) ≤ 2 (ECOG scale). 5. BCLC stage B, some patients in stage C (Vp2-3). 6. The patient&#xD;
        and/or his family agreed to join the clinical trial and sign the informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Have received TACE or other local treatment for liver cancer (except bridged liver&#xD;
             transplantation).&#xD;
&#xD;
             2. Main portal vein tumor thrombus or complicated with extrahepatic metastasis. 3.&#xD;
             Tumor burden≥70% , diffuse liver cancer or tumor is not suitable for mRECIST standard&#xD;
             evaluation.&#xD;
&#xD;
             4. Have received systemic chemotherapy, sorafinib or other targeted therapy or&#xD;
             immunotherapy.&#xD;
&#xD;
             5. Estimated life expectancy of &lt;3 months. 6. There is a significant decrease in white&#xD;
             blood cells and platelets in peripheral blood, severe coagulation dysfunction and can&#xD;
             not be corrected：the neutrophil&lt;1.5×109/L, PLT&lt;50×109/L. The INR&gt;2.3.&#xD;
&#xD;
             7. Renal dysfunction：serum creatinine (SCR) &gt;176.8 μmol/L（2 mg/dL）or creatinine&#xD;
             clearance rate (Ccr) &lt;30 mL/min.&#xD;
&#xD;
             8. Serious heart, lung, brain or other important organ diseases. 9. Pregnant or&#xD;
             lactating women. 10. cannot cooperate with TACE operation and sign informed consent&#xD;
             form.&#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>Zhiping Yan, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fudan University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Interventional Radiology, Zhongshan Hospital, Fudan University.</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 26, 2020</study_first_submitted>
  <study_first_submitted_qc>July 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>September 23, 2021</last_update_submitted>
  <last_update_submitted_qc>September 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 24, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hepatocellular Carcinoma</keyword>
  <keyword>Transarterial Chemoembolization</keyword>
  <keyword>lenvatinib</keyword>
  <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>Lenvatinib</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/NCT04490694
org study id: B2019-151R
nct id: NCT04490694
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
It is an exploratory clinical study aimed to evaluate the efficacy and safety of TACE
      combined with Lenvatinib in the treatment of patients with BCLC stage B and C HCC.Treatment
      will continue until the death or intolerable toxicity or patients withdrawal of consent,and
      the target sample size is 54 individuals.
This is a prospective, single-center and single-arm exploratory clinical study designed to
      evaluate the efficacy and safety of TACE combined with Lenvatinib in the treatment of
      patients with BCLC stage B and C hepatocellular carcinoma.Treatment will continue until the
      death or intolerable toxicity or patients withdrawal of consent,and the target sample size is
      54 individuals.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Time to progression（TTP）
time frame: 2 years
description: The time from the beginning of randomization to the tumor progression of the patient
measure: Objective remission rate（ORR）
time frame: 2 years
description: ORR according to modified RECIST for Hepatocellular Carcinoma
measure: Adverse Events
time frame: 2 years
description: Adverse event (AE)、Treatment emergent adverse event(TEAE)、Serious adverse event (SAE)
measure: Overall survival
time frame: 5 years
description: the survival time after randomization
arm group label: TACE Combined with Lenvatinib
arm group type: Experimental
intervention type: Drug
intervention name: Lenvatinib
description: Intervention Description：lenvatinib will be administered daily (for patients <60kg, lenvatinib 8mg bid po for patients ≥60kg, lenvatinib 12mg bid po) until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
arm group label: TACE Combined with Lenvatinib
other name: Lenvatinib treatment
intervention type: Procedure
intervention name: TACE
description: Patients will be treated with TACE 2-4 weeks after randomization: the blood supply of the tumor will be evaluated by transradial / femoral artery approach, microcatheter will be inserted into the tumor feeding artery, and lipiodol plus epirubicin emulsifier will be injected (40mg epirubicin will be added to each 10ml lipiodol, the total amount should less than 20ml, epirubicin 40-60mg). Gelatin sponge particles / microspheres are used to strengthen embolization. Blood biochemical examination will be performed within 1 week before TACE, 3 days after operation and 1 month after operation.
arm group label: TACE Combined with Lenvatinib
other name: Transcatheter arterial chemoembolization
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Zhiping Yan, M.D.
role: Principal Investigator
affiliation: Fudan University
facility: 
country: China
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular
mesh term: Lenvatinib