<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/NCT03239158</url>
  </required_header>
  <id_info>
    <org_study_id>Bioinformation-liver</org_study_id>
    <nct_id>NCT03239158</nct_id>
  </id_info>
  <brief_title>Bioinformation Therapy for Liver Cancer</brief_title>
  <official_title>Combination of Cancer Ablation and Life Information Rehabilitation Therapy for Unresectable Liver Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fuda Cancer Hospital, Guangzhou</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shengxin Biotechnology Institute, Beijing</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fuda Cancer Hospital, Guangzhou</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>
      The aim of this study is the synergistic effect of cancer ablation and life information&#xD;
      rehabilitation therapy on unresectable liver cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      By enrolling patients with unresectable liver cancer adapted to enrolled criteria, this study&#xD;
      will document for the first time the synergistic effect of cancer ablation and life&#xD;
      information rehabilitation therapy. The efficacy will be evaluated according to local relief&#xD;
      degree, progress free survival (PFS) and overall survival (OS).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2, 2017</start_date>
  <completion_date type="Actual">September 2, 2018</completion_date>
  <primary_completion_date type="Actual">September 2, 2018</primary_completion_date>
  <phase>Phase 2/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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Relief degree of tumors</measure>
    <time_frame>3 months</time_frame>
    <description>It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progress free survival（PFS）</measure>
    <time_frame>1 year</time_frame>
    <description>The duration between treatment and cancer recurrence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival（OS）</measure>
    <time_frame>3 years</time_frame>
    <description>The duration between treatment and patient pass away</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Liver, Cancer of, Non-Resectable</condition>
  <arm_group>
    <arm_group_label>Cancer ablation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In this group, the patients will receive ablation therapy (e.g. cryosurgery or irreversible electroporation) first for big tumors (&gt; 2 cm). The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Life information rehabilitation therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In this group, the patients will drink &quot;Qilisheng&quot; Immunoregulatory Oral Solution for consecutive 3 months. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Combination therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this group, the patients will receive the combination therapy including ablation and life information rehabilitation therapy. The ablation therapy (e.g. cryosurgery or irreversible electroporation) will be performed first for big tumors (&gt; 2 cm), then &quot;Qilisheng&quot; Immunoregulatory Oral Solution will be provided for consecutive 3 months. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>In this group, the patients will receive no special treatment and as a control group. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cancer ablation</intervention_name>
    <description>Tumors bigger than 2 cm are fit for ablation therapy, percutaneously under CT scan or ultrasound.</description>
    <arm_group_label>Cancer ablation</arm_group_label>
    <arm_group_label>Combination therapy</arm_group_label>
    <other_name>Cryoablation or irreversible electroporation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Life information rehabilitation therapy</intervention_name>
    <description>Each treatment: one bottle solution each day, consecutive 3 months, oral administration</description>
    <arm_group_label>Combination therapy</arm_group_label>
    <arm_group_label>Life information rehabilitation therapy</arm_group_label>
    <other_name>&quot;Qilisheng&quot; Immunoregulatory Oral Solution</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All standard therapies have failed according to NCCN guidelines or the patient refuses&#xD;
             standard therapies&#xD;
&#xD;
          -  Body tumor 1-6, with at least one tumor length &gt; 2 cm&#xD;
&#xD;
          -  KPS ≥ 70, lifespan &gt; 6 months&#xD;
&#xD;
          -  Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥&#xD;
             2×109/L, hemoglobin ≥ 80 g/L&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with cardiac pacemaker&#xD;
&#xD;
          -  Patients with brain metastasis&#xD;
&#xD;
          -  Patients with grade 3 hypertension or diabetic complication, severe cardiac and&#xD;
             pulmonary dysfunction&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Fuda cancer institute of Fuda cancer hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510665</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>January 23, 2019</last_update_submitted>
  <last_update_submitted_qc>January 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cancer ablation</keyword>
  <keyword>Life information rehabilitation therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Neoplasms</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/NCT03239158
org study id: Bioinformation-liver
nct id: NCT03239158
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study is the synergistic effect of cancer ablation and life information
      rehabilitation therapy on unresectable liver cancer.
By enrolling patients with unresectable liver cancer adapted to enrolled criteria, this study
      will document for the first time the synergistic effect of cancer ablation and life
      information rehabilitation therapy. The efficacy will be evaluated according to local relief
      degree, progress free survival (PFS) and overall survival (OS).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Relief degree of tumors
time frame: 3 months
description: It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）
measure: Progress free survival（PFS）
time frame: 1 year
description: The duration between treatment and cancer recurrence
measure: Overall survival（OS）
time frame: 3 years
description: The duration between treatment and patient pass away
arm group label: Cancer ablation
arm group type: Active Comparator
description: In this group, the patients will receive ablation therapy (e.g. cryosurgery or irreversible electroporation) first for big tumors (> 2 cm). The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
arm group label: Life information rehabilitation therapy
arm group type: Active Comparator
description: In this group, the patients will drink "Qilisheng" Immunoregulatory Oral Solution for consecutive 3 months. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
arm group label: Combination therapy
arm group type: Experimental
description: In this group, the patients will receive the combination therapy including ablation and life information rehabilitation therapy. The ablation therapy (e.g. cryosurgery or irreversible electroporation) will be performed first for big tumors (> 2 cm), then "Qilisheng" Immunoregulatory Oral Solution will be provided for consecutive 3 months. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
arm group label: Control
arm group type: No Intervention
description: In this group, the patients will receive no special treatment and as a control group. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
intervention type: Device
intervention name: Cancer ablation
description: Tumors bigger than 2 cm are fit for ablation therapy, percutaneously under CT scan or ultrasound.
arm group label: Cancer ablation
arm group label: Combination therapy
other name: Cryoablation or irreversible electroporation
intervention type: Drug
intervention name: Life information rehabilitation therapy
description: Each treatment: one bottle solution each day, consecutive 3 months, oral administration
arm group label: Combination therapy
arm group label: Life information rehabilitation therapy
other name: "Qilisheng" Immunoregulatory Oral Solution
criteria: 
gender: All
minimum age: 30 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor
mesh term: Liver Neoplasms