<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/NCT03243916</url>
  </required_header>
  <id_info>
    <org_study_id>ChinaPLAGH-MHCC</org_study_id>
    <nct_id>NCT03243916</nct_id>
  </id_info>
  <brief_title>Targeted and Staged Cyber Knife Combined With Interventional Therapy in the Treatment of MHCC</brief_title>
  <official_title>A Prospective Single-arm Study on Targeted and Staged Cyber Knife Combined With Interventional Therapy in the Treatment of Massive Hepatocellular Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese PLA General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese PLA General Hospital</source>
  <oversight_info>
    <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 is a highly malignant tumor that is progressing rapidly. Hepatic&#xD;
      arterial embolization chemotherapy (TACE) is a common method for the treatment of&#xD;
      unresectable of hepatocellular carcinoma.But for patients with &gt; 10cm hepatocellular&#xD;
      carcinoma, the intervention effect was not satisfied.The cyberknife is a kind of stereotactic&#xD;
      radiotherapy which can track the movement of tumor and monitor the position deviation of&#xD;
      tumor in real time.This stuy is aimed to observe the efficiency and safety of the combination&#xD;
      of TACE and cyberknife in the treatment of massive hepatocellular carcinoma.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 15, 2017</start_date>
  <completion_date type="Anticipated">July 14, 2020</completion_date>
  <primary_completion_date type="Anticipated">July 14, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>response rate(RR)</measure>
    <time_frame>18 months</time_frame>
    <description>CR(complete response)+PR(partial response)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>overall survival(OS)</measure>
    <time_frame>26mounth</time_frame>
    <description>Overall survival was defined as the time from enrollment to death from any cause.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>adverse event(AE)</measure>
    <time_frame>36 month</time_frame>
    <description>Progression Free Survival is defined as the time from enrollment to the date of first documented disease progression or death from any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (QOL)</measure>
    <time_frame>36 month</time_frame>
    <description>A questionnaire with questions referred to simple assessments of physical abilities</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Hepatocellular Carcinoma</condition>
  <arm_group>
    <arm_group_label>combination</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TACE plus cyber knife</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>TACE plus Cyber knife</intervention_name>
    <description>Patients with histologically confirmed MHCC(Massive Hepatocellular Carcinoma) will receive TACE therapy,after 1 or 2 week's recovery from hepatic insufficiency ,the targeted and staged cyber knife will be given</description>
    <arm_group_label>combination</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically or cytologically confirmed hepatocellular carcinoma&#xD;
&#xD;
          -  No lymph node metastasis or distant metastasis&#xD;
&#xD;
          -  Tumor diameter at least 10 cm&#xD;
&#xD;
          -  Hepatic lesions are not suitable for surgical resection or the patient refuse to&#xD;
             surgical treatment&#xD;
&#xD;
          -  Eastern Clinical Oncology Group (ECOG)score is 0， 1or2&#xD;
&#xD;
          -  No history of abdominal radiotherapy&#xD;
&#xD;
          -  Inoperable and untransplantable,Child-pugh score A or B&#xD;
&#xD;
          -  Normal liver volume exceeds 700 cm3&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous history of abdominal radiotherapy;&#xD;
&#xD;
          -  The maximum diameter of tumor is less than 10cm;&#xD;
&#xD;
          -  The liver Child is graded C;&#xD;
&#xD;
          -  Contraindication for radiotherapy;&#xD;
&#xD;
          -  Active gastrointestinal bleeding occurred within 2 weeks before enrollment&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Undergoing chemotherapy throughout the past six months&#xD;
&#xD;
          -  Diffuse hepatocellular carcinoma&#xD;
&#xD;
          -  Main portal vein tumor embolization&#xD;
&#xD;
          -  Undergoing other simultaneous treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yu Li, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>China PLA hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xiaoliang liu, MD</last_name>
    <phone>+86 15801570739</phone>
    <email>szy957@aliyun.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chinese PLA Gereral Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Yu Li, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 6, 2017</study_first_submitted>
  <study_first_submitted_qc>August 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>August 6, 2017</last_update_submitted>
  <last_update_submitted_qc>August 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese PLA General Hospital</investigator_affiliation>
    <investigator_full_name>YuLi</investigator_full_name>
    <investigator_title>Vice Director of Department of Radiotherappy</investigator_title>
  </responsible_party>
  <keyword>interventional therapy</keyword>
  <keyword>TACE</keyword>
  <keyword>Cyberknife</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>
  <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/NCT03243916
org study id: ChinaPLAGH-MHCC
nct id: NCT03243916
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Hepatocellular carcinoma is a highly malignant tumor that is progressing rapidly. Hepatic
      arterial embolization chemotherapy (TACE) is a common method for the treatment of
      unresectable of hepatocellular carcinoma.But for patients with > 10cm hepatocellular
      carcinoma, the intervention effect was not satisfied.The cyberknife is a kind of stereotactic
      radiotherapy which can track the movement of tumor and monitor the position deviation of
      tumor in real time.This stuy is aimed to observe the efficiency and safety of the combination
      of TACE and cyberknife in the treatment of massive hepatocellular carcinoma.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: response rate(RR)
time frame: 18 months
description: CR(complete response)+PR(partial response)
measure: overall survival(OS)
time frame: 26mounth
description: Overall survival was defined as the time from enrollment to death from any cause.
measure: adverse event(AE)
time frame: 36 month
description: Progression Free Survival is defined as the time from enrollment to the date of first documented disease progression or death from any cause
measure: Quality of life (QOL)
time frame: 36 month
description: A questionnaire with questions referred to simple assessments of physical abilities
arm group label: combination
arm group type: Experimental
description: TACE plus cyber knife
intervention type: Radiation
intervention name: TACE plus Cyber knife
description: Patients with histologically confirmed MHCC(Massive Hepatocellular Carcinoma) will receive TACE therapy,after 1 or 2 week's recovery from hepatic insufficiency ,the targeted and staged cyber knife will be given
arm group label: combination
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Yu Li, MD
role: Principal Investigator
affiliation: China PLA hospital
last name: Xiaoliang liu, MD
phone: +86 15801570739
email: szy957@aliyun.com
facility: 
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Chinese PLA General Hospital
investigator full name: YuLi
investigator title: Vice Director of Department of Radiotherappy
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular
sharing ipd: Undecided