<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/NCT02253511</url>
  </required_header>
  <id_info>
    <org_study_id>CD-2014</org_study_id>
    <secondary_id>NST-CD</secondary_id>
    <nct_id>NCT02253511</nct_id>
  </id_info>
  <brief_title>A Prospective Control Study of Cidan Capsule Combined With TACE in Hepatocellular Carcinoma</brief_title>
  <official_title>A Prospective Randomized Control Study of Cidan Capsule Combined With Transcatheter Arterial Chemoembolization in Hepatocellular Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zheng Donghai</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing Weida Cancer Hospital of Chinese Traditional Medical Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hepatocellular carcinoma (HCC) is one of the most common malignances seen in different&#xD;
      regions of the world. The 5-year risk of recurrence of HCC after resection has been reported&#xD;
      to be as high as 70%. It has been proposed that best way to reduce recurrence is to search&#xD;
      for improved adjuvant therapies. Especially for some postoperative patients who were&#xD;
      identified with the risk factors for recurrence, several adjuvant therapies were often used,&#xD;
      including TACE. Recently, a variety of Traditional Chinese Medicine combined with TACE for&#xD;
      toxicity reduction and enhancing the efficacy have been investigated in the treatment of HCC.&#xD;
      Cidan capsules are a formula containing more than ten types of plant extracts, and has been&#xD;
      clinically used for &gt;10 years as a safe and nontoxic antitumor drug. However, the safy and&#xD;
      efficacy of preventive therapy is still not clear. In this prospective control study, we&#xD;
      enroll such HCC patients experienced operation and were identifed with high risk of&#xD;
      recurrence. After a preventive TACE, the eligible patients were divided into two groups. One&#xD;
      group will accept Cidan therapy and another will not. Under a basis of large sample, the&#xD;
      safty and efficacy of Cidan combined with TACE in HCC patients will be investigated and&#xD;
      analysed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hepatocellular carcinoma (HCC) is one of the most common malignances seen in different&#xD;
      regions of the world. Surgical resection provides the best chance of cure for selected&#xD;
      patients. However, we have long been perplexed by high rates of tumor recurrence, which is&#xD;
      often the main cause of long-term treatment failure. The 5-year risk of recurrence of HCC&#xD;
      after resection has been reported to be as high as 70%. It has been proposed that best way to&#xD;
      reduce recurrence is to search for improved adjuvant therapies. Especially for some&#xD;
      postoperative patients who were identified with the risk factors for recurrence, several&#xD;
      adjuvant therapies were often used, including TACE. However, the safy and efficacy of&#xD;
      preventive therapy is still not clear.&#xD;
&#xD;
      Recently, a variety of Traditional Chinese Medicine combined with TACE for toxicity reduction&#xD;
      and enhancing the efficacy have been investigated in the treatment of HCC. Cidan capsules are&#xD;
      a formula containing more than ten types of plant extracts, including Rhizoma Curcumae (19%),&#xD;
      Astragalus (19.6%), Cremastra appendiculata (9.8%), Salvia miltiorrhiza (9.8%), hive (9.8%)&#xD;
      and Bombyx batryticatus (9.8%). Cidan has been clinically used for &gt;10 years as a safe and&#xD;
      nontoxic antitumor drug. A number of studies have investigated the clinical application of&#xD;
      TCMs for HCC, demonstrating that β-elemene, which is present in Rhizoma Curcumae and the main&#xD;
      component of cidan, may inhibit the proliferation of HepG2 cells in a time- and&#xD;
      dose-dependent manner. The results indicated that β-elemene exhibited positive effects on&#xD;
      apoptosis and induced the cell cycle arrest of HepG2 cells in the G2/M phase, while Fas and&#xD;
      Fas ligand expression levels were markedly increased.&#xD;
&#xD;
      In this prospective control study, we enroll such HCC patients experienced operation and were&#xD;
      identifed with high risk of recurrence. After a preventive TACE, the eligible patients were&#xD;
      divided into two groups. One group will accept Cidan therapy and another will not. Under a&#xD;
      basis of large sample, the safty and efficacy of Cidan combined with TACE in HCC patients&#xD;
      will be investigated and analysed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">July 2017</completion_date>
  <primary_completion_date type="Anticipated">July 2017</primary_completion_date>
  <phase>Phase 4</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>Overall survival</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Recurrence-free survival</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of participants with adverse events</measure>
    <time_frame>3 years</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Hepatocellular Carcinoma</condition>
  <arm_group>
    <arm_group_label>Cidan capsule</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients who undergone operation and TACE were administered 1.35 g cidan capsules (Weida Pharmaceutical Co., Ltd., Beijing, China) three times a day for 3 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients were only accepted operation and TACE.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cidan capsule</intervention_name>
    <arm_group_label>Cidan capsule</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of HCC confirmed by pathology.&#xD;
&#xD;
          -  Liver function of Child-Pugh Class A or B.&#xD;
&#xD;
          -  no intrahepatic and extrahepatic metastasis.&#xD;
&#xD;
          -  Tumors had not invaded the portal vein, the hepatic vein trunk or the secondary&#xD;
             branches.&#xD;
&#xD;
          -  Patients undergone operation were confirmed to have the following high-risk recurrence&#xD;
             factors:&#xD;
&#xD;
        Satellite nodules, Poor differentiation, Tumor diameter &gt; 5cm&#xD;
&#xD;
          -  No evidence of coagulopathy: platelet count &gt; 50 × 109/L and a prolonged prothrombin&#xD;
             time of &lt; 5 seconds.&#xD;
&#xD;
          -  The patients would like to accept postoperative TACE.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Informed consent not available&#xD;
&#xD;
          -  Impaired liver function with either clinically detected ascites, hepatic&#xD;
             encephalopathy, serum albumin &lt; 25g/L or bilirubin &gt; 50micromol/L&#xD;
&#xD;
          -  Renal impairment with creatinine &gt; 200micromol/L&#xD;
&#xD;
          -  Severe concurrent medical illness persisting &gt; 6 weeks after hepatectomy&#xD;
&#xD;
          -  History of other cancer&#xD;
&#xD;
          -  Pregnant women&#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>Mengchao Wu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Eastern Hepatobiliary Surgery Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Donghai Zheng, MD</last_name>
    <phone>8613501182949</phone>
    <email>rippleoo@sohu.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Eastern Hepatobiliary Surgery Hospital</name>
      <address>
        <city>Shanghai</city>
        <zip>200438</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wenjie Dong, MD</last_name>
      <phone>8615810115565</phone>
      <email>microripple@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>September 29, 2014</last_update_submitted>
  <last_update_submitted_qc>September 29, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 1, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Beijing Weida Cancer Hospital of Chinese Traditional Medical Sciences</investigator_affiliation>
    <investigator_full_name>Zheng Donghai</investigator_full_name>
    <investigator_title>Vice-President of Beijing Weida Cancer Hospital of Chinese Traditional Medical Sciences</investigator_title>
  </responsible_party>
  <keyword>Hepatocellular carcinoma</keyword>
  <keyword>Hepotectomy</keyword>
  <keyword>Recurrence-free survival</keyword>
  <keyword>Overall survival</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/NCT02253511
org study id: CD-2014
secondary id: NST-CD
nct id: NCT02253511
lead sponsor: 
has dmc: Yes
Hepatocellular carcinoma (HCC) is one of the most common malignances seen in different
      regions of the world. The 5-year risk of recurrence of HCC after resection has been reported
      to be as high as 70%. It has been proposed that best way to reduce recurrence is to search
      for improved adjuvant therapies. Especially for some postoperative patients who were
      identified with the risk factors for recurrence, several adjuvant therapies were often used,
      including TACE. Recently, a variety of Traditional Chinese Medicine combined with TACE for
      toxicity reduction and enhancing the efficacy have been investigated in the treatment of HCC.
      Cidan capsules are a formula containing more than ten types of plant extracts, and has been
      clinically used for >10 years as a safe and nontoxic antitumor drug. However, the safy and
      efficacy of preventive therapy is still not clear. In this prospective control study, we
      enroll such HCC patients experienced operation and were identifed with high risk of
      recurrence. After a preventive TACE, the eligible patients were divided into two groups. One
      group will accept Cidan therapy and another will not. Under a basis of large sample, the
      safty and efficacy of Cidan combined with TACE in HCC patients will be investigated and
      analysed.
Hepatocellular carcinoma (HCC) is one of the most common malignances seen in different
      regions of the world. Surgical resection provides the best chance of cure for selected
      patients. However, we have long been perplexed by high rates of tumor recurrence, which is
      often the main cause of long-term treatment failure. The 5-year risk of recurrence of HCC
      after resection has been reported to be as high as 70%. It has been proposed that best way to
      reduce recurrence is to search for improved adjuvant therapies. Especially for some
      postoperative patients who were identified with the risk factors for recurrence, several
      adjuvant therapies were often used, including TACE. However, the safy and efficacy of
      preventive therapy is still not clear.

      Recently, a variety of Traditional Chinese Medicine combined with TACE for toxicity reduction
      and enhancing the efficacy have been investigated in the treatment of HCC. Cidan capsules are
      a formula containing more than ten types of plant extracts, including Rhizoma Curcumae (19%),
      Astragalus (19.6%), Cremastra appendiculata (9.8%), Salvia miltiorrhiza (9.8%), hive (9.8%)
      and Bombyx batryticatus (9.8%). Cidan has been clinically used for >10 years as a safe and
      nontoxic antitumor drug. A number of studies have investigated the clinical application of
      TCMs for HCC, demonstrating that β-elemene, which is present in Rhizoma Curcumae and the main
      component of cidan, may inhibit the proliferation of HepG2 cells in a time- and
      dose-dependent manner. The results indicated that β-elemene exhibited positive effects on
      apoptosis and induced the cell cycle arrest of HepG2 cells in the G2/M phase, while Fas and
      Fas ligand expression levels were markedly increased.

      In this prospective control study, we enroll such HCC patients experienced operation and were
      identifed with high risk of recurrence. After a preventive TACE, the eligible patients were
      divided into two groups. One group will accept Cidan therapy and another will not. Under a
      basis of large sample, the safty and efficacy of Cidan combined with TACE in HCC patients
      will be investigated and analysed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall survival
time frame: 3 years
measure: Recurrence-free survival
time frame: 3 years
measure: Number of participants with adverse events
time frame: 3 years
arm group label: Cidan capsule
arm group type: Experimental
description: Patients who undergone operation and TACE were administered 1.35 g cidan capsules (Weida Pharmaceutical Co., Ltd., Beijing, China) three times a day for 3 months.
arm group label: Control group
arm group type: No Intervention
description: Patients were only accepted operation and TACE.
intervention type: Drug
intervention name: Cidan capsule
arm group label: Cidan capsule
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Mengchao Wu, MD
role: Principal Investigator
affiliation: Eastern Hepatobiliary Surgery Hospital
last name: Donghai Zheng, MD
phone: 8613501182949
email: rippleoo@sohu.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Beijing Weida Cancer Hospital of Chinese Traditional Medical Sciences
investigator full name: Zheng Donghai
investigator title: Vice-President of Beijing Weida Cancer Hospital of Chinese Traditional Medical Sciences
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular