<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/NCT04459754</url>
  </required_header>
  <id_info>
    <org_study_id>2019KT1089</org_study_id>
    <nct_id>NCT04459754</nct_id>
  </id_info>
  <brief_title>Fuzheng Yiliu-1010</brief_title>
  <official_title>Based on the Real World Prospective Cohort Study, Two-way Analysis of the Dominant Population and Corresponding Phenotypic Characteristics of Patients With Colorectal Cancer Treated by Fuzheng Yiliu Therapy Combined With Adjuvant Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guangdong Provincial Hospital of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guangdong Provincial Hospital of Traditional Chinese Medicine</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>
      Real world study was used to evaluate the therapeutic effect of Fuzheng anti-tumor therapy on&#xD;
      colorectal cancer patients in stage II and III after surgery and standard chemotherapy, and&#xD;
      the prediction model of dominant population of Fuzheng anti-tumor therapy was constructed by&#xD;
      using real-world data and gene expression profile data.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 29, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Disease-free Survival</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">189</enrollment>
  <condition>Colorectal Cancer Stage II and III</condition>
  <arm_group>
    <arm_group_label>Fuzheng Yiliu group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fuzheng Yiliu Formulation</intervention_name>
    <description>The &quot;prescription for colorectal cancer&quot; Fuzheng Yiliu formulation is a combination of 13 herbal components and it is available in granules form to be dissolved in hot water for consumption.</description>
    <arm_group_label>Fuzheng Yiliu group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The age of the patients was 18-75 years old;&#xD;
&#xD;
          2. Radical resection of colorectal cancer (negative margin) was performed;&#xD;
&#xD;
          3. Patients with stage II high risk and stage III colorectal cancer confirmed by&#xD;
             histology;&#xD;
&#xD;
          4. No liver, peritoneal or distant metastasis was found;&#xD;
&#xD;
          5. Patients with colorectal cancer who received standard chemotherapy or radiotherapy&#xD;
             after operation and had no recurrence or metastasis at the end of radiotherapy and&#xD;
             chemotherapy;&#xD;
&#xD;
          6. ECoG (Eastern Cooperative Oncology Group) score was 0-1; KPS score was 70 or above;&#xD;
&#xD;
          7. Liver function: SGOT and SGPT were less than 1.5 times of normal value, bilirubin was&#xD;
             less than 1.5 mg / dl;&#xD;
&#xD;
          8. Renal function: creatinine &lt; 1.8mg/dl.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Allergic to the drug of this scheme;&#xD;
&#xD;
          2. Pregnant or lactating women with fertility requirements during the study period;&#xD;
&#xD;
          3. Severe hypertension, coronary heart disease, diabetes and so on, which are under&#xD;
             control for half a year due to cardiovascular accident and poor drug control, are&#xD;
             accompanied with other uncontrollable benign diseases such as lung, kidney, liver,&#xD;
             infection, etc;&#xD;
&#xD;
          4. Participate in other studies before and during treatment;&#xD;
&#xD;
          5. There was a history of other malignant tumors or multi-source tumors within one year;&#xD;
&#xD;
          6. Chronic hepatitis B or C (high copy viral DNA) or activity in HIV infection history or&#xD;
             active phase;&#xD;
&#xD;
          7. Patients with tuberculosis or seizures who need to be treated (e.g. steroids or&#xD;
             antiepileptic therapy).&#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_contact>
    <last_name>wei wang, MD</last_name>
    <phone>8613922255515</phone>
    <email>ww1640@yeah.net</email>
  </overall_contact>
  <location>
    <facility>
      <name>Guangdong Provincial Hospital of Chinese Medicine</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wei Wang, MD</last_name>
      <phone>13922255515</phone>
      <email>ww1640@yeah.net</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>July 2, 2020</last_update_submitted>
  <last_update_submitted_qc>July 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine</investigator_affiliation>
    <investigator_full_name>Wei Wang</investigator_full_name>
    <investigator_title>Guangzhou University of Chinese Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal 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/NCT04459754
org study id: 2019KT1089
nct id: NCT04459754
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Real world study was used to evaluate the therapeutic effect of Fuzheng anti-tumor therapy on
      colorectal cancer patients in stage II and III after surgery and standard chemotherapy, and
      the prediction model of dominant population of Fuzheng anti-tumor therapy was constructed by
      using real-world data and gene expression profile data.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Disease-free Survival
time frame: 3 years
arm group label: Fuzheng Yiliu group
arm group type: Experimental
arm group label: control group
arm group type: No Intervention
intervention type: Drug
intervention name: Fuzheng Yiliu Formulation
description: The "prescription for colorectal cancer" Fuzheng Yiliu formulation is a combination of 13 herbal components and it is available in granules form to be dissolved in hot water for consumption.
arm group label: Fuzheng Yiliu group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: wei wang, MD
phone: 8613922255515
email: ww1640@yeah.net
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
investigator full name: Wei Wang
investigator title: Guangzhou University of Chinese Medicine
mesh term: Colorectal Neoplasms