<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/NCT01715532</url>
  </required_header>
  <id_info>
    <org_study_id>HCS-2012</org_study_id>
    <nct_id>NCT01715532</nct_id>
  </id_info>
  <brief_title>Role of Huachansu in Treating Hepatocellular Carcinoma and the Correlation With Na+/K+-ATPase</brief_title>
  <official_title>Phase II Study of Huachansu for Treatment of Advanced Hepatocellular Carcinoma and the Correlation With Na+/K+-ATPase</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fudan University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Primary Outcome Measures:&#xD;
&#xD;
      - To compare the progression free survival(PFS) in patients with unresectable hepatocellular&#xD;
      carcinoma(HCC) treated with transcatheter arterial chemoembolization(TACE) with or without&#xD;
      Huachansu, and the correlation between PFS and expression of peripheral Na+/K+-ATPase α3&#xD;
      family.&#xD;
&#xD;
      Secondary Outcome Measures:&#xD;
&#xD;
      - To compare the overall survival(OS), objective response rate(ORR), and side effects of&#xD;
      treating HCC with TACE plus Huachansu or TACE alone.&#xD;
&#xD;
      Exploratory Outcome Measures:&#xD;
&#xD;
      - To evaluate the correlation between prognosis and expression of peripheral Na+/K+-ATPase α3&#xD;
      family.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2012</start_date>
  <completion_date type="Anticipated">June 2016</completion_date>
  <primary_completion_date type="Anticipated">June 2016</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>Progression free survival</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 100 months.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>From date of randomization until the date of death, assessed up to 100 months.</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Carcinoma, Hepatocellular</condition>
  <arm_group>
    <arm_group_label>Huachansu + TACE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this arm will receive Huachansu tablets each 3 and 3 times a day orally, as well as transcatheter arterial chemoembolization every 4 weeks, until progression of disease or adverse effects leading to termination of treatment. Each 4-week period is one cycle of treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TACE</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in this arm will receive transcatheter arterial chemoembolization every 4 weeks, until progression of disease or adverse effects leading to termination of treatment. Each 4-week period is one cycle of treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Huachansu</intervention_name>
    <arm_group_label>Huachansu + TACE</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>TACE</intervention_name>
    <arm_group_label>Huachansu + TACE</arm_group_label>
    <arm_group_label>TACE</arm_group_label>
    <other_name>transcatheter arterial chemoembolization</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female subjects 18-75 years of age.&#xD;
&#xD;
          -  Diagnosis of hepatocellular carcinoma. Biopsy is the preferred method of diagnosis&#xD;
             (option 1). As far as clinically possible, the results of a biopsy should be obtained&#xD;
             to confirm the diagnosis prior to the initiation of investigational product&#xD;
             administration.. Non-biopsy criteria are allowed in cases where a biopsy result is&#xD;
             unavailable and a biopsy procedure is not clinically indicated (option 2). (Option 1:&#xD;
             Biopsy-proven HCC (histology or cytology); Option 2 - patient must fulfill the&#xD;
             following criteria: i. Radiological evidence of HCC showing lesion arterial&#xD;
             hypervascularity and venous phase washout by either dynamic (triple-phase),&#xD;
             contrast-enhanced computed tomography of the abdomen OR dynamic (triple-phase)&#xD;
             contrast (gadolinium)-enhanced MRI, AND ii. Serology positive for hepatitis B or C,&#xD;
             AND iii. Alpha fetoprotein &gt; 400 μg/L at the time of diagnosis.)&#xD;
&#xD;
          -  No metastasis outside liver.&#xD;
&#xD;
          -  Unable or unwilling to receive radical surgery.&#xD;
&#xD;
          -  No prior transcatheter arterial chemoembolization.&#xD;
&#xD;
          -  No prior treatment of bufalins including Huachansu.&#xD;
&#xD;
          -  At least one measurable untreated lesion. All subjects must have at least one&#xD;
             measurable lesion unidimensionally by CT or MRI scan, according to modified RECIST for&#xD;
             HCC, that has not been previously treated with surgery, irradiation, radiofrequency&#xD;
             ablation, percutaneous ethanol or acetic acid injection, or cryoablation.&#xD;
&#xD;
          -  Cirrhotic status of Child-Pugh Class A or B.&#xD;
&#xD;
          -  Adequate hematologic function with absolute neutrophil counts ≥ 1.5×109 /L, platelet&#xD;
             count ≥ 50 x 109/L, and hemoglobin ≥ 85 g/L.&#xD;
&#xD;
          -  Signed Written Informed Consent.&#xD;
&#xD;
          -  Subjects who have a life expectancy of at least 3 months.&#xD;
&#xD;
          -  Women of childbearing potential (WOCBP) must be using an adequate method of&#xD;
             contraception to avoid pregnancy throughout the study that the risk of pregnancy is&#xD;
             minimized.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previously treated target lesion with irradiation, TACE, radiofrequency ablation,&#xD;
             percutaneous ethanol or acetic acid injection, or cryoablation.&#xD;
&#xD;
          -  Cirrhotic status of Child-Pugh Class C.&#xD;
&#xD;
          -  Severe diseases of heart, liver, kidney, etc that may cause inadequate organ functions&#xD;
&#xD;
          -  History of other malignant tumor in 5 years.&#xD;
&#xD;
          -  Pregnant or lactating women.&#xD;
&#xD;
          -  Mentally disordered.&#xD;
&#xD;
          -  Participation of other clinical trials within a month.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hao Chen, MD, Ph D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fudan University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yehua Shen, MD</last_name>
    <phone>86-21-64175590</phone>
    <phone_ext>83625</phone_ext>
    <email>yehuash25@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Fudan University Shanghai Cancer Center</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yehua Shen, MD</last_name>
      <phone>86-21-64175590</phone>
      <phone_ext>83625</phone_ext>
      <email>yehuash25@163.com</email>
    </contact>
    <investigator>
      <last_name>Hao Chen, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>August 17, 2012</study_first_submitted>
  <study_first_submitted_qc>October 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <last_update_submitted>December 16, 2015</last_update_submitted>
  <last_update_submitted_qc>December 16, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 18, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fudan University</investigator_affiliation>
    <investigator_full_name>Hao Chen</investigator_full_name>
    <investigator_title>Associated Professor, MD, Ph D</investigator_title>
  </responsible_party>
  <keyword>Huachansu</keyword>
  <keyword>Na+/K+-ATPase α3</keyword>
  <keyword>transcatheter arterial chemoembolization</keyword>
  <keyword>randomized controlled trial</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>
  <!-- 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/NCT01715532
org study id: HCS-2012
nct id: NCT01715532
lead sponsor: 
has dmc: Yes
Primary Outcome Measures:

      - To compare the progression free survival(PFS) in patients with unresectable hepatocellular
      carcinoma(HCC) treated with transcatheter arterial chemoembolization(TACE) with or without
      Huachansu, and the correlation between PFS and expression of peripheral Na+/K+-ATPase α3
      family.

      Secondary Outcome Measures:

      - To compare the overall survival(OS), objective response rate(ORR), and side effects of
      treating HCC with TACE plus Huachansu or TACE alone.

      Exploratory Outcome Measures:

      - To evaluate the correlation between prognosis and expression of peripheral Na+/K+-ATPase α3
      family.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression free survival
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 100 months.
measure: Overall survival
time frame: From date of randomization until the date of death, assessed up to 100 months.
arm group label: Huachansu + TACE
arm group type: Experimental
description: Patients in this arm will receive Huachansu tablets each 3 and 3 times a day orally, as well as transcatheter arterial chemoembolization every 4 weeks, until progression of disease or adverse effects leading to termination of treatment. Each 4-week period is one cycle of treatment.
arm group label: TACE
arm group type: Active Comparator
description: Patients in this arm will receive transcatheter arterial chemoembolization every 4 weeks, until progression of disease or adverse effects leading to termination of treatment. Each 4-week period is one cycle of treatment.
intervention type: Drug
intervention name: Huachansu
arm group label: Huachansu + TACE
intervention type: Other
intervention name: TACE
arm group label: Huachansu + TACE
arm group label: TACE
other name: transcatheter arterial chemoembolization
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Hao Chen, MD, Ph D
role: Principal Investigator
affiliation: Fudan University
last name: Yehua Shen, MD
phone: 86-21-64175590
phone ext: 83625
email: yehuash25@163.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Fudan University
investigator full name: Hao Chen
investigator title: Associated Professor, MD, Ph D
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular