<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/NCT03808766</url>
  </required_header>
  <id_info>
    <org_study_id>VIR-18-09</org_study_id>
    <nct_id>NCT03808766</nct_id>
  </id_info>
  <brief_title>A Study on the Angioarchitecture of Hepatocellular Carcinoma</brief_title>
  <official_title>A Study on the Angioarchitecture of Hepatocellular Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese University of Hong Kong</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>
      Hepatocellular carcinoma (HCC) is one of the commonest solid malignancies in Hong Kong as&#xD;
      well as globally. Transarterial therapy has been playing an important role in the treatment&#xD;
      algorithm for patients with HCC. The primary purpose of transarterial therapy is eradication&#xD;
      of the viability of the targeted tumors. The treatment outcomes have been variable among the&#xD;
      various treatments, in general, there is still much room for improvement, especially for&#xD;
      large size tumors. From the studies on Transarterial chemoembolization (TACE), it is known&#xD;
      that the treatment outcome is affected by the nature and the formulation of therapeutic&#xD;
      agents that are delivered, which is related to the angioarchitecture of the tumor. Knowledge&#xD;
      on the angioarchitecture of HCC is essential for the understanding of the requirements for&#xD;
      effective transarterial treatment of HCC. This prospective study is aimed to study the&#xD;
      angioarchitecture of HCC.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Embolization is performed within 2 weeks before the scheduled date of partial hepatectomy.&#xD;
      The purpose of the timing is two folded, it allows observation of the embolization effect to&#xD;
      be differentiated among the various embolic agents, it also allows time for the patient and&#xD;
      the liver to recover from the embolization.&#xD;
&#xD;
      The patient then receives partial hepatectomy within 2 weeks unless the result of liver&#xD;
      function tests shows contraindication to surgery, in which case the liver function test is&#xD;
      further evaluated on a weekly basis until the findings are acceptable, and surgery is&#xD;
      scheduled accordingly.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Poor patient accrual&#xD;
  </why_stopped>
  <start_date type="Actual">August 13, 2018</start_date>
  <completion_date type="Actual">April 17, 2023</completion_date>
  <primary_completion_date type="Actual">April 17, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Tumors are categorized into 3 groups based on the longest diameter of the largest tumor:&#xD;
Group 1: ≤3cm Group 2: &gt;3cm to 7cm Group 3: &gt;7cm</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>arterial flow through the tumor</measure>
    <time_frame>within one hour</time_frame>
    <description>Digital subtraction angiography (DSA) is performed before and after embolization, through catheterization of the arterial branches supplying the tumor, images from arterial phase to delayed phase are captured. Contrast distribution at the arterial tumor branches, arterioles, tumor sinusoids, peri-tumoral liver, and peri-tumoral portal venules are observed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The degree of tumor necrosis</measure>
    <time_frame>within 2 weeks after embolization</time_frame>
    <description>The percentage of viable residual HCC is assessed quantitatively in increments of 5 %, with the measurement of the largest axial diameter of viable HCC compared to that of the whole tumor using a microscopic ruler.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Carcinoma, Hepatocellular</condition>
  <arm_group>
    <arm_group_label>Tumor &lt;=3cm</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Embolization with particulate or liquid embolic agent</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tumor &gt;3cm to 7cm</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Embolization with particulate or liquid embolic agent</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tumor &gt; 7cm</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Embolization with particulate or liquid embolic agent</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>embolization</intervention_name>
    <description>Patient with a diagnosis of HCC and a treatment plan to receive partial hepatectomy will receive transarterial embolization under local anesthesia 2 weeks before the surgery. Angiographic examinations of the tumor before and after embolization of the tumor will be performed. Histological examination of the tumor in the surgical specimens will be performed.</description>
    <arm_group_label>Tumor &lt;=3cm</arm_group_label>
    <arm_group_label>Tumor &gt; 7cm</arm_group_label>
    <arm_group_label>Tumor &gt;3cm to 7cm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age above 18 years&#xD;
&#xD;
          2. HCC suitable for partial hepatectomy&#xD;
&#xD;
          3. Child-Pugh A or B cirrhosis&#xD;
&#xD;
          4. Eastern Cooperative Oncology Group performance score 0 or 1&#xD;
&#xD;
          5. Barcelona clinic liver cancer (BCLC) staging A or B&#xD;
&#xD;
          6. HCC diagnosed by typical enhancement patterns on cross sectional imaging or histology&#xD;
&#xD;
          7. Massive expansive tumor morphology with measurable lesion on CT (characterized by&#xD;
             well-defined spherical or globular configuration, with or without tumor capsule or&#xD;
             satellite lesions)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous treatment with liver resection, ablation, chemotherapy, radiotherapy or&#xD;
             transarterial embolization (with or without chemotherapy),&#xD;
&#xD;
          2. Evidence of tumor invasion of portal vein or hepatic vein&#xD;
&#xD;
          3. History of acute tumor rupture presenting with hemo-peritoneum&#xD;
&#xD;
          4. Infiltrative tumor morphology (characterized by ill- defined tumor margin and&#xD;
             amorphous configuration) or diffuse tumor morphology (characterized by large number of&#xD;
             small nodules)&#xD;
&#xD;
          5. Serum creatinine level &gt; 150umol/L&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Simon Yu</last_name>
    <role>Principal Investigator</role>
    <affiliation>DIIR, CUHK, Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>October 10, 2018</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>April 28, 2023</last_update_submitted>
  <last_update_submitted_qc>April 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Simon Yu</investigator_full_name>
    <investigator_title>Professor</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>
  <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/NCT03808766
org study id: VIR-18-09
nct id: NCT03808766
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Hepatocellular carcinoma (HCC) is one of the commonest solid malignancies in Hong Kong as
      well as globally. Transarterial therapy has been playing an important role in the treatment
      algorithm for patients with HCC. The primary purpose of transarterial therapy is eradication
      of the viability of the targeted tumors. The treatment outcomes have been variable among the
      various treatments, in general, there is still much room for improvement, especially for
      large size tumors. From the studies on Transarterial chemoembolization (TACE), it is known
      that the treatment outcome is affected by the nature and the formulation of therapeutic
      agents that are delivered, which is related to the angioarchitecture of the tumor. Knowledge
      on the angioarchitecture of HCC is essential for the understanding of the requirements for
      effective transarterial treatment of HCC. This prospective study is aimed to study the
      angioarchitecture of HCC.
Embolization is performed within 2 weeks before the scheduled date of partial hepatectomy.
      The purpose of the timing is two folded, it allows observation of the embolization effect to
      be differentiated among the various embolic agents, it also allows time for the patient and
      the liver to recover from the embolization.

      The patient then receives partial hepatectomy within 2 weeks unless the result of liver
      function tests shows contraindication to surgery, in which case the liver function test is
      further evaluated on a weekly basis until the findings are acceptable, and surgery is
      scheduled accordingly.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Tumors are categorized into 3 groups based on the longest diameter of the largest tumor:
Group 1: ≤3cm Group 2: >3cm to 7cm Group 3: >7cm
primary purpose: Other
masking: None (Open Label)
measure: arterial flow through the tumor
time frame: within one hour
description: Digital subtraction angiography (DSA) is performed before and after embolization, through catheterization of the arterial branches supplying the tumor, images from arterial phase to delayed phase are captured. Contrast distribution at the arterial tumor branches, arterioles, tumor sinusoids, peri-tumoral liver, and peri-tumoral portal venules are observed.
measure: The degree of tumor necrosis
time frame: within 2 weeks after embolization
description: The percentage of viable residual HCC is assessed quantitatively in increments of 5 %, with the measurement of the largest axial diameter of viable HCC compared to that of the whole tumor using a microscopic ruler.
arm group label: Tumor <=3cm
arm group type: Other
description: Embolization with particulate or liquid embolic agent
arm group label: Tumor >3cm to 7cm
arm group type: Other
description: Embolization with particulate or liquid embolic agent
arm group label: Tumor > 7cm
arm group type: Other
description: Embolization with particulate or liquid embolic agent
intervention type: Other
intervention name: embolization
description: Patient with a diagnosis of HCC and a treatment plan to receive partial hepatectomy will receive transarterial embolization under local anesthesia 2 weeks before the surgery. Angiographic examinations of the tumor before and after embolization of the tumor will be performed. Histological examination of the tumor in the surgical specimens will be performed.
arm group label: Tumor <=3cm
arm group label: Tumor > 7cm
arm group label: Tumor >3cm to 7cm
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Simon Yu
role: Principal Investigator
affiliation: DIIR, CUHK, Hong Kong
facility: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: Simon Yu
investigator title: Professor
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular
sharing ipd: No