xml: <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/NCT06023147</url>
    </required_header>
    <id_info>
      <org_study_id>2023-KY-0737-002</org_study_id>
      <nct_id>NCT06023147</nct_id>
    </id_info>
    <brief_title>A Real-world Study of the Short-term Efficacy and Safety of E-TACE in Patients With Hepatocellular Carcinoma (HCC)</brief_title>
    <official_title>A Real-world Study of the Short-term Efficacy and Safety of Elaboration Transcatheter Arterial Chemoembolization (E-TACE) in Patients With Hepatocellular Carcinoma (HCC)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Xuhua Duan</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The First Affiliated Hospital of Zhengzhou University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a real world study to determine the short-term efficacy and safety of Elaboration&#xD;
        transcatheter arterial chemoembolization (E-TACE) for hepatocellular carcinoma (HCC)&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Primary liver cancer is the fourth common malignant tumor and the second cause of death in&#xD;
        China, which seriously threatens the life and health of Chinese people. Hepatocellular&#xD;
        carcinoma accounts for 75% to 85% of primary liver cancer and is considered the leading cause&#xD;
        of death in patients with cirrhosis, and its incidence is expected to continue to increase.&#xD;
  &#xD;
        At present, the main treatment methods of liver cancer are surgical resection, liver&#xD;
        transplantation, interventional therapy, etc., HCC patients are often advanced in initial&#xD;
        diagnosis, coupled with cirrhosis, liver function intolerance and other factors, only about&#xD;
        15% of patients can receive surgical resection. Transcatheter arterial chemoembolization&#xD;
        (TACE) has been applied in hepatocellular carcinoma for more than 40 years. TACE treatment&#xD;
        can be divided into conventional TACE and Drug-eluting beads-transarterial chemoembolization&#xD;
        (DEB-TACE) according to different embolic agents. DEB-TACE refers to the embolization therapy&#xD;
        based on drug-eluting microspheres loaded with chemotherapy drugs, which can embolize the&#xD;
        blood supplying artery of liver cancer to cause tumor ischemia and necrosis. At the same&#xD;
        time, as a carrier of chemotherapy drugs, DEB-TACE has the advantage of continuously and&#xD;
        steadily releasing drugs, so that the local tumor can reach a higher required concentration.&#xD;
        Elaboration transcatheter arterial chemoembolization (E-TACE) is the elaboration&#xD;
        transcatheter arterial branch selection of the tumor and the refined embolization is carried&#xD;
        out by using uniform drug-loaded microsphere.&#xD;
  &#xD;
        Although there have been a large number of randomized controlled studies on TACE treatment of&#xD;
        HCC, due to the clear inclusion or exclusion criteria of randomized controlled studies. The&#xD;
        results of the studies are different from the real diagnosis and treatment environment due to&#xD;
        the limitations of treatment programs. This difference is called the efficacy effectiveness&#xD;
        gap (EEG). In addition, the 2022 edition of China Liver Cancer Standard Diagnosis and&#xD;
        Treatment Quality Control Indicators and 2022 edition of Primary Liver Cancer Diagnosis and&#xD;
        Treatment Guidelines point out that TACE treatment for liver cancer needs to be standardized&#xD;
        and refined, to reduce the heterogeneity of tumors leading to differences in TACE efficacy,&#xD;
        and ultimately improve the survival rate and survival habits of liver cancer patients. There&#xD;
        are currently no real-world studies on the efficacy and safety of E-TACE in the treatment of&#xD;
        hepatocellular carcinoma. Therefore, this study intends to conduct a real-world study to&#xD;
        evaluate the short-term efficacy and safety of E-TACE in the treatment of hepatocellular&#xD;
        carcinoma.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 10, 2023</start_date>
    <completion_date type="Anticipated">September 10, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 10, 2024</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>Objective response rate (ORR)</measure>
      <time_frame>1, 3, 6,12 months after the first E-TACE treatment, up to death or 12 months</time_frame>
      <description>Proportion of patients with reduction in stable in tumor burden of a predefined amount</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>6/12 months progression-free survival (PFS) rate</measure>
      <time_frame>6/12 months</time_frame>
      <description>Rate of progression free survival in 6/12 months</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>6/12 months overall survival (OS) rate</measure>
      <time_frame>6/12 months</time_frame>
      <description>Rate of over survival rate in 6/12 months</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease control rate (DCR)</measure>
      <time_frame>1, 3, 6,12 months after the first E-TACE treatment, up to death or 12 months</time_frame>
      <description>Proportion of patients with reduction or keeping in stable in tumor burden of a predefined amount</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">298</enrollment>
    <condition>Hepatocellular Carcinoma</condition>
    <arm_group>
      <arm_group_label>E-TACE</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Procedure: The 100μm drug-loaded microspheres were loaded with 40mg-80mg anthracyclines at one milliliter/two milliliter (1mL/2mL), and then combined with non-isoionic contrast agents to embolize the tumor supplying arteries, and then 250μm or 400μm drug-loaded microspheres were loaded with 1mL/2mL chemotherapy drugs to embolize the tumor supplying arteries at different grades and diameters.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>E-TACE</intervention_name>
      <description>The 100μm drug-loaded microspheres were loaded with 40mg-80mg anthracyclines at 1mL/2mL, and then combined with non-isoionic contrast agents to embolize the tumor supplying arteries, and then 250μm or 400μm drug-loaded microspheres were loaded with 1mL/2mL chemotherapy drugs to embolize the tumor supplying arteries at different grades and diameters.</description>
      <arm_group_label>E-TACE</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Gender and age are not limited;&#xD;
  &#xD;
            2. HCC patients who strictly meet the clinical diagnostic criteria of the Guidelines for&#xD;
               Diagnosis and Treatment of Primary Liver Cancer (2022 edition) or who have been&#xD;
               confirmed by histopathology or cytology;&#xD;
  &#xD;
            3. Patients who have at least one tumor supply artery available for superselection, and&#xD;
               who are assessed by investigators or multi-disciplinary treatment (MDT) to require&#xD;
               E-TACE therapy;&#xD;
  &#xD;
            4. Patients sign informed consent and have good compliance.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          1.Patients judged by the investigators to be unsuitable for inclusion in this study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Xuhua Duan</last_name>
      <role>Principal Investigator</role>
      <affiliation>The First Affiliated Hospital of Zhengzhou University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Xuhua Duan</last_name>
      <phone>+8613523402912</phone>
      <email>xuhuaduan@163.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Xinwei Han</last_name>
      <phone>13803842129</phone>
      <email>zzudxh@yeah.net</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Huai He Hospital of Henan University</name>
        <address>
          <city>Kaifeng</city>
          <state>Henan</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Xiang He</last_name>
      </contact>
      <investigator>
        <last_name>Xiang He</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Luo He Central Hospital</name>
        <address>
          <city>Luohe</city>
          <state>Henan</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Yaoxian Liu</last_name>
      </contact>
      <investigator>
        <last_name>Yaoxian Liu</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>WuYang People's Hospital</name>
        <address>
          <city>Luohe</city>
          <state>Henan</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Chenguang Pang</last_name>
      </contact>
      <investigator>
        <last_name>Chenguang Pang</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Luo Yang Central Hospital</name>
        <address>
          <city>Luoyang</city>
          <state>Henan</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Fazhong Li</last_name>
        <phone>18537919361</phone>
      </contact>
      <investigator>
        <last_name>Fazhong Li</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Henan University of science and Technology</name>
        <address>
          <city>Luoyang</city>
          <state>Henan</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Huanzhang Niu</last_name>
        <phone>18567635732</phone>
        <email>niuhuanzhang@126.com</email>
      </contact>
      <investigator>
        <last_name>Huanzhang Niu</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>The Second Affiliated Hospital of Henan University of Science and Technology</name>
        <address>
          <city>Luoyang</city>
          <state>Henan</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Liyu Song</last_name>
      </contact>
      <investigator>
        <last_name>Liyu Song</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Deng zhou People's Hospital</name>
        <address>
          <city>Nanyang</city>
          <state>Henan</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Xuguo Dan</last_name>
      </contact>
      <investigator>
        <last_name>Xuguo Dan</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>yanliang Li</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>First People's Hospital of Ping Dingshan</name>
        <address>
          <city>Pingdingshan</city>
          <state>Henan</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Hengfei Ma</last_name>
      </contact>
      <investigator>
        <last_name>Hengfei Ma</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>General Hospital of Pingmei Shenma Group</name>
        <address>
          <city>Pingdingshan</city>
          <state>Henan</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Peixin Zhu</last_name>
      </contact>
      <investigator>
        <last_name>Peixin Zhu</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Lushan Xian People's Hospital</name>
        <address>
          <city>Pingdingshan</city>
          <state>Henan</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Yanchun Li</last_name>
      </contact>
      <investigator>
        <last_name>Yanchun Li</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Second People's Hospital of Ping Dingshan</name>
        <address>
          <city>Pingdingshan</city>
          <state>Henan</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Kunli Cao</last_name>
      </contact>
      <investigator>
        <last_name>Kunli Cao</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>The 989 Hospital of the Chinese People's Liberation Army Joint Logistic Support Force</name>
        <address>
          <city>Pingdingshan</city>
          <state>Henan</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Yanliang Feng</last_name>
      </contact>
      <investigator>
        <last_name>Yanliang Feng</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Puyang People's Hospital</name>
        <address>
          <city>Puyang</city>
          <state>Henan</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Guangli Chen</last_name>
      </contact>
      <investigator>
        <last_name>Guangli Chen</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>San Menxia Central Hospital</name>
        <address>
          <city>Sanmenxia</city>
          <state>Henan</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Zhenping Li</last_name>
      </contact>
      <investigator>
        <last_name>Zhenping Li</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Yellow River San Menxia Hospital</name>
        <address>
          <city>Sanmenxia</city>
          <state>Henan</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Hailong Gong</last_name>
      </contact>
      <investigator>
        <last_name>Hailong Gong</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Central Hospital of Yongcheng</name>
        <address>
          <city>Shangqiu</city>
          <state>Henan</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Zuoyu Liang</last_name>
      </contact>
      <investigator>
        <last_name>Zuoyu Liang</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>First People's Hospital of Shangqiu</name>
        <address>
          <city>Shangqiu</city>
          <state>Henan</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Jian Zhou</last_name>
      </contact>
      <investigator>
        <last_name>Jian Zhou</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Shangqiu Municipal Hospital</name>
        <address>
          <city>Shangqiu</city>
          <state>Henan</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Baoning Guo</last_name>
      </contact>
      <investigator>
        <last_name>Baoning Guo</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>The People's Hospital of Yongcheng</name>
        <address>
          <city>Shangqiu</city>
          <state>Henan</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Yi Zhao</last_name>
      </contact>
      <investigator>
        <last_name>Yi Zhao</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Tumor Hospital of Xinyang</name>
        <address>
          <city>Xinyang</city>
          <state>Henan</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Ting Lei</last_name>
      </contact>
      <investigator>
        <last_name>Ting Lei</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Henan Provincial People's Hospital</name>
        <address>
          <city>Zhengzhou</city>
          <state>Henan</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Guangshao Cao</last_name>
        <phone>15093103069</phone>
        <email>yajuncao98@126.com</email>
      </contact>
      <investigator>
        <last_name>Guangshao Cao</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>The Sixth Peoples Hospital of Zhengzhou</name>
        <address>
          <city>Zhengzhou</city>
          <state>Henan</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Dengke Zhang</last_name>
      </contact>
      <investigator>
        <last_name>Dengke Zhang</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>The Third Peoples Hospital of Zhengzhou</name>
        <address>
          <city>Zhengzhou</city>
          <state>Henan</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Dong Wei</last_name>
      </contact>
      <investigator>
        <last_name>Dong Wei</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>First People's Hospital of Zhoukou</name>
        <address>
          <city>Zhoukou</city>
          <state>Henan</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Haibo Wang</last_name>
      </contact>
      <investigator>
        <last_name>Haibo Wang</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Xihua Xian People's Hospital</name>
        <address>
          <city>Zhoukou</city>
          <state>Henan</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Hongjie Wang</last_name>
      </contact>
      <investigator>
        <last_name>Hongjie Wang</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Zhou Kou Central Hospital</name>
        <address>
          <city>Zhoukou</city>
          <state>Henan</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Cheng Xing</last_name>
        <phone>18336547709</phone>
      </contact>
      <investigator>
        <last_name>Zhou Kou Xing</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Zhou Kou Hospital of TCM</name>
        <address>
          <city>Zhoukou</city>
          <state>Henan</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Changran Wang</last_name>
      </contact>
      <investigator>
        <last_name>Changran Wang</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>The First Affiliated Hospital of Zhengzhou University</investigator_affiliation>
      <investigator_full_name>Xuhua Duan</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <keyword>E-TACE</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>
  
  
text: 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/NCT06023147
  org study id: 2023-KY-0737-002
  nct id: NCT06023147
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a real world study to determine the short-term efficacy and safety of Elaboration
        transcatheter arterial chemoembolization (E-TACE) for hepatocellular carcinoma (HCC)
  Primary liver cancer is the fourth common malignant tumor and the second cause of death in
        China, which seriously threatens the life and health of Chinese people. Hepatocellular
        carcinoma accounts for 75% to 85% of primary liver cancer and is considered the leading cause
        of death in patients with cirrhosis, and its incidence is expected to continue to increase.
  
        At present, the main treatment methods of liver cancer are surgical resection, liver
        transplantation, interventional therapy, etc., HCC patients are often advanced in initial
        diagnosis, coupled with cirrhosis, liver function intolerance and other factors, only about
        15% of patients can receive surgical resection. Transcatheter arterial chemoembolization
        (TACE) has been applied in hepatocellular carcinoma for more than 40 years. TACE treatment
        can be divided into conventional TACE and Drug-eluting beads-transarterial chemoembolization
        (DEB-TACE) according to different embolic agents. DEB-TACE refers to the embolization therapy
        based on drug-eluting microspheres loaded with chemotherapy drugs, which can embolize the
        blood supplying artery of liver cancer to cause tumor ischemia and necrosis. At the same
        time, as a carrier of chemotherapy drugs, DEB-TACE has the advantage of continuously and
        steadily releasing drugs, so that the local tumor can reach a higher required concentration.
        Elaboration transcatheter arterial chemoembolization (E-TACE) is the elaboration
        transcatheter arterial branch selection of the tumor and the refined embolization is carried
        out by using uniform drug-loaded microsphere.
  
        Although there have been a large number of randomized controlled studies on TACE treatment of
        HCC, due to the clear inclusion or exclusion criteria of randomized controlled studies. The
        results of the studies are different from the real diagnosis and treatment environment due to
        the limitations of treatment programs. This difference is called the efficacy effectiveness
        gap (EEG). In addition, the 2022 edition of China Liver Cancer Standard Diagnosis and
        Treatment Quality Control Indicators and 2022 edition of Primary Liver Cancer Diagnosis and
        Treatment Guidelines point out that TACE treatment for liver cancer needs to be standardized
        and refined, to reduce the heterogeneity of tumors leading to differences in TACE efficacy,
        and ultimately improve the survival rate and survival habits of liver cancer patients. There
        are currently no real-world studies on the efficacy and safety of E-TACE in the treatment of
        hepatocellular carcinoma. Therefore, this study intends to conduct a real-world study to
        evaluate the short-term efficacy and safety of E-TACE in the treatment of hepatocellular
        carcinoma.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Objective response rate (ORR)
  time frame: 1, 3, 6,12 months after the first E-TACE treatment, up to death or 12 months
  description: Proportion of patients with reduction in stable in tumor burden of a predefined amount
  measure: 6/12 months progression-free survival (PFS) rate
  time frame: 6/12 months
  description: Rate of progression free survival in 6/12 months
  measure: 6/12 months overall survival (OS) rate
  time frame: 6/12 months
  description: Rate of over survival rate in 6/12 months
  measure: Disease control rate (DCR)
  time frame: 1, 3, 6,12 months after the first E-TACE treatment, up to death or 12 months
  description: Proportion of patients with reduction or keeping in stable in tumor burden of a predefined amount
  arm group label: E-TACE
  arm group type: Experimental
  description: Procedure: The 100μm drug-loaded microspheres were loaded with 40mg-80mg anthracyclines at one milliliter/two milliliter (1mL/2mL), and then combined with non-isoionic contrast agents to embolize the tumor supplying arteries, and then 250μm or 400μm drug-loaded microspheres were loaded with 1mL/2mL chemotherapy drugs to embolize the tumor supplying arteries at different grades and diameters.
  intervention type: Procedure
  intervention name: E-TACE
  description: The 100μm drug-loaded microspheres were loaded with 40mg-80mg anthracyclines at 1mL/2mL, and then combined with non-isoionic contrast agents to embolize the tumor supplying arteries, and then 250μm or 400μm drug-loaded microspheres were loaded with 1mL/2mL chemotherapy drugs to embolize the tumor supplying arteries at different grades and diameters.
  arm group label: E-TACE
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Xuhua Duan
  role: Principal Investigator
  affiliation: The First Affiliated Hospital of Zhengzhou University
  last name: Xuhua Duan
  phone: +8613523402912
  email: xuhuaduan@163.com
  last name: Xinwei Han
  phone: 13803842129
  email: zzudxh@yeah.net
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  country: China
  responsible party type: Sponsor-Investigator
  investigator affiliation: The First Affiliated Hospital of Zhengzhou University
  investigator full name: Xuhua Duan
  investigator title: Associate Professor
  mesh term: Carcinoma
  mesh term: Carcinoma, Hepatocellular