<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/NCT03268499</url>
  </required_header>
  <id_info>
    <org_study_id>VIR-14-07</org_study_id>
    <nct_id>NCT03268499</nct_id>
  </id_info>
  <brief_title>TACE Emulsion Versus Suspension</brief_title>
  <official_title>Lipiodol-based Transcatheter Arterial Chemoembolization for Unresectable Hepatocellular Carcinoma: A Randomized Controlled Trial of Aqueous Cisplatin Emulsion Versus Cisplatin Particle Suspension</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>
      The aim of the study was to evaluate the safety and efficacy of using the new formulation&#xD;
      (Lipiodol-cisplatin suspension) for TACE in the treatment of HCC as compared to the&#xD;
      conventional formulation (Lipiodol-cisplatin emulsion). This is a prospective,&#xD;
      parallel-group, open-label randomized, phase II study that is conducted in accordance to the&#xD;
      Declaration of Helsinki and international standards of Good Clinical Practice, and approved&#xD;
      by the institutional review board. Eligible patients were randomized into either a treatment&#xD;
      arm of Lipiodol-cisplatin suspension or a control arm of Lipiodol-cisplatin emulsion with a&#xD;
      1:1 ratio.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Transcatheter arterial chemoembolization (TACE) has been playing an important role in the&#xD;
      treatment algorithm for patients with multifocal or large intrahepatic lesions not eligible&#xD;
      for surgical resection, transplantation, or local ablative therapy. In Hong Kong, the TACE&#xD;
      regimen currently being utilized in the great majority of hospitals is based on an aqueous&#xD;
      form of cisplatin (1mg per mL) mixed in a one-to-one ratio by volume with Lipiodol to form a&#xD;
      relatively large volume of 40mL emulsion at 20mg cisplatin as the maximum dose. Although TACE&#xD;
      with this regimen has been shown to be effective in prolonging overall survival, there is&#xD;
      probably room for further improvement because the objective tumor response rate is limited to&#xD;
      39%. One of the approaches to improve the treatment effectiveness of TACE could be to&#xD;
      increase the dose of chemotherapeutic agent. In the United States, the most common regimen of&#xD;
      chemotherapeutic agent in TACE is the mixture of cisplatin 100mg, doxorubicin 50mg, and&#xD;
      mitomycin C 10mg, dissolved in 10ml of water-soluble contrast medium, then emulsified in an&#xD;
      equivalent volume of lipiodol to form a 20mL emulsion. A relatively new regimen was&#xD;
      introduced, in which a relatively high dose of cisplatin up to 100mg in particle form was&#xD;
      given as a suspension in 20mL of Lipiodol, this regimen has been used and found to achieve an&#xD;
      improved objective tumor response rate of 51%.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 9, 2016</start_date>
  <completion_date type="Actual">April 28, 2023</completion_date>
  <primary_completion_date type="Actual">February 28, 2023</primary_completion_date>
  <phase>Phase 2</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to progression (TTP)</measure>
    <time_frame>within 30 days of a treatment procedure</time_frame>
    <description>The interval between the randomization date and the date of radiological progression, including intralesional progression, extralesional progression, or extra-hepatic progression.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">77</enrollment>
  <condition>Hepatocellular Carcinoma</condition>
  <arm_group>
    <arm_group_label>Lipiodol-cisplatin suspension</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Lipiodol-cisplatin emulsion</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisplatin</intervention_name>
    <description>The procedure of TACE is the same irrespective of which regimen is used.</description>
    <arm_group_label>Lipiodol-cisplatin emulsion</arm_group_label>
    <arm_group_label>Lipiodol-cisplatin suspension</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Written informed consent&#xD;
&#xD;
          2. Age above 18 years&#xD;
&#xD;
          3. HCC unsuitable for resection or ablation&#xD;
&#xD;
          4. Child-Pugh A cirrhosis&#xD;
&#xD;
          5. Eastern Cooperative Oncology Group performance score 0 or 1&#xD;
&#xD;
          6. BCLC A or B&#xD;
&#xD;
          7. No previous treatment for HCC except for liver resection&#xD;
&#xD;
          8. HCC diagnosed by typical enhancement patterns on cross sectional imaging or histology.&#xD;
&#xD;
          9. No extra-hepatic involvement on non-enhanced CT thorax and triphasic contrast enhanced&#xD;
             CT abdomen.&#xD;
&#xD;
         10. No invasion of portal vein or hepatic vein&#xD;
&#xD;
         11. 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;
         12. Total tumor mass &lt; 50% liver volume&#xD;
&#xD;
         13. Size of any individual tumor &lt;= 12cm in largest dimension&#xD;
&#xD;
         14. Serum creatinine &lt; 130 umol/L or Creatinine clearance &gt; 55 ml/min.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Known active malignancy within the last 3 years&#xD;
&#xD;
          2. History of acute tumor rupture presenting with hemo-peritoneum&#xD;
&#xD;
          3. Biliary obstruction not amenable to percutaneous or endoscopic drainage&#xD;
&#xD;
          4. Child-Pugh B or C cirrhosis&#xD;
&#xD;
          5. History of hepatic encephalopathy&#xD;
&#xD;
          6. Intractable ascites not controllable by medical therapy&#xD;
&#xD;
          7. History of variceal bleeding within last 3 months&#xD;
&#xD;
          8. 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;
          9. Incorrectable Arterio-portal venous shunt affecting &gt;1 hepatic segment on CT&#xD;
&#xD;
         10. Arterial-hepatic venous shunt with hepatic vein opacified in arterial phase on CT&#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>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>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</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 1, 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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cisplatin</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/NCT03268499
org study id: VIR-14-07
nct id: NCT03268499
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of the study was to evaluate the safety and efficacy of using the new formulation
      (Lipiodol-cisplatin suspension) for TACE in the treatment of HCC as compared to the
      conventional formulation (Lipiodol-cisplatin emulsion). This is a prospective,
      parallel-group, open-label randomized, phase II study that is conducted in accordance to the
      Declaration of Helsinki and international standards of Good Clinical Practice, and approved
      by the institutional review board. Eligible patients were randomized into either a treatment
      arm of Lipiodol-cisplatin suspension or a control arm of Lipiodol-cisplatin emulsion with a
      1:1 ratio.
Transcatheter arterial chemoembolization (TACE) has been playing an important role in the
      treatment algorithm for patients with multifocal or large intrahepatic lesions not eligible
      for surgical resection, transplantation, or local ablative therapy. In Hong Kong, the TACE
      regimen currently being utilized in the great majority of hospitals is based on an aqueous
      form of cisplatin (1mg per mL) mixed in a one-to-one ratio by volume with Lipiodol to form a
      relatively large volume of 40mL emulsion at 20mg cisplatin as the maximum dose. Although TACE
      with this regimen has been shown to be effective in prolonging overall survival, there is
      probably room for further improvement because the objective tumor response rate is limited to
      39%. One of the approaches to improve the treatment effectiveness of TACE could be to
      increase the dose of chemotherapeutic agent. In the United States, the most common regimen of
      chemotherapeutic agent in TACE is the mixture of cisplatin 100mg, doxorubicin 50mg, and
      mitomycin C 10mg, dissolved in 10ml of water-soluble contrast medium, then emulsified in an
      equivalent volume of lipiodol to form a 20mL emulsion. A relatively new regimen was
      introduced, in which a relatively high dose of cisplatin up to 100mg in particle form was
      given as a suspension in 20mL of Lipiodol, this regimen has been used and found to achieve an
      improved objective tumor response rate of 51%.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Time to progression (TTP)
time frame: within 30 days of a treatment procedure
description: The interval between the randomization date and the date of radiological progression, including intralesional progression, extralesional progression, or extra-hepatic progression.
arm group label: Lipiodol-cisplatin suspension
arm group type: Active Comparator
arm group label: Lipiodol-cisplatin emulsion
arm group type: Active Comparator
intervention type: Drug
intervention name: Cisplatin
description: The procedure of TACE is the same irrespective of which regimen is used.
arm group label: Lipiodol-cisplatin emulsion
arm group label: Lipiodol-cisplatin suspension
criteria: 
gender: All
minimum age: 18 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
mesh term: Cisplatin
sharing ipd: No