<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/NCT03777475</url>
  </required_header>
  <id_info>
    <org_study_id>B2017-005-01</org_study_id>
    <nct_id>NCT03777475</nct_id>
  </id_info>
  <brief_title>the Effect of Different Oxaliplatin Dose in Transarterial Infusion (TAI) in Unresectable Hepatocellular Carcinoma</brief_title>
  <official_title>the Effect of Different Oxaliplatin Dose in Transarterial Infusion (TAI) in Unresectable Hepatocellular Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sun Yat-sen University</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>
      evaluate the effect of different oxaliplatin dose in TAI in treating unresectable HCC.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 1, 2016</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2021</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>OS</measure>
    <time_frame>From date of randomization until the date of death from any cause, assessed up to 60 months</time_frame>
    <description>overall survival</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ORR</measure>
    <time_frame>From date of randomization until the date of death from any cause, assessed up to 60 months</time_frame>
    <description>object response rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PFS</measure>
    <time_frame>From date of randomization until the date of progress from any cause, assessed up to 60 months</time_frame>
    <description>progression-free survival</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">350</enrollment>
  <condition>Hepatocellular Carcinoma</condition>
  <arm_group>
    <arm_group_label>low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>low oxaliplatin (85mg/m2)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>high dose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>high oxaliplatin (135mg/m2)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>transarterial infusion</intervention_name>
    <description>transarterial infusion</description>
    <arm_group_label>high dose</arm_group_label>
    <arm_group_label>low dose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  older than 18 years old and younger than 75 years;&#xD;
&#xD;
          -  ECOG PS≤1;&#xD;
&#xD;
          -  proven hepatocellular carcinoma according patological examination or EASL/AASLD&#xD;
             diagnostic criteria;&#xD;
&#xD;
          -  not previous treated for tumor;&#xD;
&#xD;
          -  unresectable;&#xD;
&#xD;
          -  the lab test could meet: neutrophil count≥2.0×109/L; hemoglobin≥100g/L; platelet&#xD;
             count≥75×109/L; serum albumin≥35g/L; total bilirubin&lt;2-times upper limit of normal;&#xD;
             ALT&lt;3-times upper limit of normal; AST&lt;3-times upper limit of normal; serum&#xD;
             creatine&lt;1.5-times upper limit of normal; PT≤upper limit of normal plus 4 seconds;&#xD;
             INR≤2.2;&#xD;
&#xD;
          -  sign up consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cannot tolerate TAI or surgery;&#xD;
&#xD;
          -  known history of other malignancy;&#xD;
&#xD;
          -  be allergic to related drugs;&#xD;
&#xD;
          -  underwent organ transplantation before;&#xD;
&#xD;
          -  be treated before (interferon included);&#xD;
&#xD;
          -  known history of HIV infection;&#xD;
&#xD;
          -  known history of drug or alcohol abuse;&#xD;
&#xD;
          -  have GI hemorrhage or cardiac/brain vascular events within 30 days;&#xD;
&#xD;
          -  pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>SUN YAT-SEN University Cancer Center</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510060</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rong-Ping Guo, M.D.</last_name>
      <phone>00862087342266</phone>
      <email>guorp@sysucc.org.cn</email>
    </contact>
    <contact_backup>
      <last_name>Wei Wei, Ph.D. M.D.</last_name>
      <phone>00862087343790</phone>
      <email>weiwei@sysucc.org.cn</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 14, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>December 14, 2018</last_update_submitted>
  <last_update_submitted_qc>December 14, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Rong-ping Guo</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>Undecided</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/NCT03777475
org study id: B2017-005-01
nct id: NCT03777475
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
evaluate the effect of different oxaliplatin dose in TAI in treating unresectable HCC.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: OS
time frame: From date of randomization until the date of death from any cause, assessed up to 60 months
description: overall survival
measure: ORR
time frame: From date of randomization until the date of death from any cause, assessed up to 60 months
description: object response rate
measure: PFS
time frame: From date of randomization until the date of progress from any cause, assessed up to 60 months
description: progression-free survival
arm group label: low dose
arm group type: Experimental
description: low oxaliplatin (85mg/m2)
arm group label: high dose
arm group type: Active Comparator
description: high oxaliplatin (135mg/m2)
intervention type: Procedure
intervention name: transarterial infusion
description: transarterial infusion
arm group label: high dose
arm group label: low dose
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Rong-ping Guo
investigator title: Professor
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular
sharing ipd: Undecided