<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/NCT02987907</url>
  </required_header>
  <id_info>
    <org_study_id>B2016-024-01</org_study_id>
    <nct_id>NCT02987907</nct_id>
  </id_info>
  <brief_title>The Impact on Therapeutic Effect and Tolerance of Treatment for Patients With Hepatocellular Carcinoma in Transcatheter Arterial Chemoembolization (TACE) of Dexamethasone Application: A Random, Double-blind, Controlled, Clinical Trial.</brief_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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The current random, double-blind, controlled, clinical trial was designed to evaluate the&#xD;
      impact on therapeutic effect and tolerance of treatment for patients with hepatocelluclar&#xD;
      carcinoma in transcatheter arterial chemoembolization (TACE) of dexamethasone application.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2016</start_date>
  <completion_date type="Anticipated">August 2019</completion_date>
  <primary_completion_date type="Anticipated">July 2019</primary_completion_date>
  <phase>Phase 3</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>response rate (RR)</measure>
    <time_frame>1 month after TACE</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>proportions of participants with severe adverse events according to CTCAE v4.03</measure>
    <time_frame>1 month after TACE</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>overall survival (OS)</measure>
    <time_frame>From date of randomization until the date of death from any cause, assessed up to 60 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>progression-free survival (PFS)</measure>
    <time_frame>From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>time to progression (TTP)</measure>
    <time_frame>From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">220</enrollment>
  <condition>HepatoCellular Carcinoma</condition>
  <arm_group>
    <arm_group_label>treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>use dexamethasone 10mg (2ml) I.A. during TACE</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>use normal saline 2ml I.A. during TACE</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>use dexamethasone 10mg (2ml) I.A. during TACE</description>
    <arm_group_label>treatment group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal Saline</intervention_name>
    <description>use normal saline 2ml I.A. during TACE</description>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  older than 18 years old;&#xD;
&#xD;
          -  ECOG PS&lt;3;&#xD;
&#xD;
          -  proven hepatocellular carcinoma according patological examination or EASL/AASLD&#xD;
             diagnostic criteria;&#xD;
&#xD;
          -  meeting at least 1/4: 1) multiple nodules, 2) single tumor but not suitable for&#xD;
             resection, 3) vascular invasion exists, 4) distant metastasis excluding CNS and bone&#xD;
&#xD;
          -  not previous treated for tumor;&#xD;
&#xD;
          -  Child-Pugh A or B;&#xD;
&#xD;
          -  at least one measurable lesion according mRECIST;&#xD;
&#xD;
          -  cannot afford sorafenib;&#xD;
&#xD;
          -  the lab test could meet: neutrophil count≥1.5×109/L; hemoglobin≥80g/L; platelet&#xD;
             count≥60×109/L; serum albumin≥28g/L; total bilirubin&lt;3-times upper limit of normal;&#xD;
             ALT&lt;5-times upper limit of normal; AST&lt;5-times upper limit of normal; serum&#xD;
             creatine&lt;1.5-times upper limit of normal; PT≤upper limit of normal plus 6 seconds;&#xD;
             INR≤2.3&#xD;
&#xD;
          -  sign up consent;&#xD;
&#xD;
          -  unrolled by other clinical trials about hepatocellular carcinoma.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cannot tolerate TACE;&#xD;
&#xD;
          -  CNS or bone metastasis exits;&#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 hemorrage 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>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Shaohua Li, MD</last_name>
    <phone>+8615088064187</phone>
    <email>lishaoh@sysucc.org.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cancer Center of Sun Yat-Sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>+86-20</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shaohua Li, MD</last_name>
      <phone>+8615088064187</phone>
      <email>lishaoh@sysucc.org.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>December 8, 2016</last_update_submitted>
  <last_update_submitted_qc>December 8, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 9, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Li Shaohua</investigator_full_name>
    <investigator_title>Attending Doctor, Department of Hepatobiliary Pancreatic Surgery</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>Dexamethasone</mesh_term>
  </intervention_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/NCT02987907
org study id: B2016-024-01
nct id: NCT02987907
lead sponsor: 
has dmc: Yes
The current random, double-blind, controlled, clinical trial was designed to evaluate the
      impact on therapeutic effect and tolerance of treatment for patients with hepatocelluclar
      carcinoma in transcatheter arterial chemoembolization (TACE) of dexamethasone application.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: response rate (RR)
time frame: 1 month after TACE
measure: proportions of participants with severe adverse events according to CTCAE v4.03
time frame: 1 month after TACE
measure: overall survival (OS)
time frame: From date of randomization until the date of death from any cause, assessed up to 60 months
measure: progression-free survival (PFS)
time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
measure: time to progression (TTP)
time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
arm group label: treatment group
arm group type: Experimental
description: use dexamethasone 10mg (2ml) I.A. during TACE
arm group label: control group
arm group type: Placebo Comparator
description: use normal saline 2ml I.A. during TACE
intervention type: Drug
intervention name: Dexamethasone
description: use dexamethasone 10mg (2ml) I.A. during TACE
arm group label: treatment group
intervention type: Drug
intervention name: Normal Saline
description: use normal saline 2ml I.A. during TACE
arm group label: control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Shaohua Li, MD
phone: +8615088064187
email: lishaoh@sysucc.org.cn
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Li Shaohua
investigator title: Attending Doctor, Department of Hepatobiliary Pancreatic Surgery
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular
mesh term: Dexamethasone
sharing ipd: Undecided