<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/NCT04424043</url>
  </required_header>
  <id_info>
    <org_study_id>B2020-127</org_study_id>
    <nct_id>NCT04424043</nct_id>
  </id_info>
  <brief_title>Neo-TACE-HAIC for BCLC B Stage HCC</brief_title>
  <acronym>NeoconceptB</acronym>
  <official_title>Neoadjuvant Transartery Chemoembolization Plus Artery Infusion Chemotherapy With Surgery Versus Surgery Alone for Hepatocellular Carcinoma Patients With Barcelona Clinic Liver Cancer (BCLC) B Stage: a Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sun Yat-sen University</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 (HCC) patients is a common disease in the East Asia. Although BCLC&#xD;
      (Barcelona clinical liver cancer) system recommend to transarterial chemoembolization (TACE)&#xD;
      for BCLC B stage patients, increasing studies suggested that hepatic resection provided&#xD;
      survival benefit for those patients. However, a relative high recurrence risk leads surgeons&#xD;
      to investigate the value of preoperative treatment.&#xD;
&#xD;
      Recently, FOLFOX (Oxaliplatin and 5-fluorouracil) based hepatic artery infusion chemotherapy&#xD;
      (HAIC) exhibited high response rate for unresectable HCC.&#xD;
&#xD;
      Pilot study showed TACE combined HAIC (TACE-HAIC) had better tumor response, with low&#xD;
      progression disease rate.&#xD;
&#xD;
      Whether TACE-HAIC would improve survival for patients with BCLC B stage is need to further to&#xD;
      study. A randomized clinical trial compared neo-TACE-HAIC with surgery versus surgery alone&#xD;
      is aimed to answer this question.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 8, 2020</start_date>
  <completion_date type="Anticipated">December 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2022</primary_completion_date>
  <phase>N/A</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>Progression-free survival, PFS</measure>
    <time_frame>36 months</time_frame>
    <description>PFS was calculated from the date of starting treatment to the date of progression, of disease or death</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival, OS</measure>
    <time_frame>60 months</time_frame>
    <description>OS was calculated from the date of starting treatment to the date of death.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">280</enrollment>
  <condition>Hepatocellular Carcinoma</condition>
  <arm_group>
    <arm_group_label>neo-TACE-HAIC with surgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>transartery chemoembolization with lipiodol and EADM, FOLFOX (Oxa 85mg/m2 2h+CF 400mg/m2 2h +5FU 400mg/m2 10min+5FU 1200mg/m2 23h)-based artery infusion chemotherapy, followed by hepatic resection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>surgery alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>hepatic resection remove the liver tumors</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>neo-TACE-HAIC+Surgery</intervention_name>
    <description>transartery chemoembolization with lipiodol and EADM, FOLFOX (Oxa 85mg/m2 2h+CF 400mg/m2 2h +5FU 400mg/m2 10min+5FU 1200mg/m2 23h)-based artery infusion chemotherapy, followed by hepatic resection</description>
    <arm_group_label>neo-TACE-HAIC with surgery</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Surgery alone</intervention_name>
    <description>hepatic resection remove the liver tumors</description>
    <arm_group_label>surgery alone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Age 18-75 years;&#xD;
&#xD;
               -  BCLC B stage and tumor number &lt;=4;&#xD;
&#xD;
               -  Patients with resectable primary hepatocellular carcinoma;&#xD;
&#xD;
               -  Child-Pugh A or B (7 score) liver function;&#xD;
&#xD;
               -  The volume of residual liver more than 30%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • With unresectable HCC&#xD;
&#xD;
               -  Pregnant woman or sucking period;&#xD;
&#xD;
               -  With other malignant cancer;&#xD;
&#xD;
               -  Received anti-HCC therapy before this study&#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>Yunfei Yuan, MD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sun Yat-sen University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jiliang Qiu, MD.</last_name>
    <phone>862087343114</phone>
    <email>qiujl@sysucc.org.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Sun Yat-sen University Cancer Center</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510060</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jiliang Qiu, MD.</last_name>
      <phone>862087343114</phone>
      <email>qiujl@sysucc.org.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>June 6, 2020</study_first_submitted>
  <study_first_submitted_qc>June 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>October 22, 2020</last_update_submitted>
  <last_update_submitted_qc>October 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Yunfei Yuan</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <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>No</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/NCT04424043
org study id: B2020-127
nct id: NCT04424043
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Hepatocellular carcinoma (HCC) patients is a common disease in the East Asia. Although BCLC
      (Barcelona clinical liver cancer) system recommend to transarterial chemoembolization (TACE)
      for BCLC B stage patients, increasing studies suggested that hepatic resection provided
      survival benefit for those patients. However, a relative high recurrence risk leads surgeons
      to investigate the value of preoperative treatment.

      Recently, FOLFOX (Oxaliplatin and 5-fluorouracil) based hepatic artery infusion chemotherapy
      (HAIC) exhibited high response rate for unresectable HCC.

      Pilot study showed TACE combined HAIC (TACE-HAIC) had better tumor response, with low
      progression disease rate.

      Whether TACE-HAIC would improve survival for patients with BCLC B stage is need to further to
      study. A randomized clinical trial compared neo-TACE-HAIC with surgery versus surgery alone
      is aimed to answer this question.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression-free survival, PFS
time frame: 36 months
description: PFS was calculated from the date of starting treatment to the date of progression, of disease or death
measure: Overall survival, OS
time frame: 60 months
description: OS was calculated from the date of starting treatment to the date of death.
arm group label: neo-TACE-HAIC with surgery
arm group type: Experimental
description: transartery chemoembolization with lipiodol and EADM, FOLFOX (Oxa 85mg/m2 2h+CF 400mg/m2 2h +5FU 400mg/m2 10min+5FU 1200mg/m2 23h)-based artery infusion chemotherapy, followed by hepatic resection
arm group label: surgery alone
arm group type: Active Comparator
description: hepatic resection remove the liver tumors
intervention type: Procedure
intervention name: neo-TACE-HAIC+Surgery
description: transartery chemoembolization with lipiodol and EADM, FOLFOX (Oxa 85mg/m2 2h+CF 400mg/m2 2h +5FU 400mg/m2 10min+5FU 1200mg/m2 23h)-based artery infusion chemotherapy, followed by hepatic resection
arm group label: neo-TACE-HAIC with surgery
intervention type: Procedure
intervention name: Surgery alone
description: hepatic resection remove the liver tumors
arm group label: surgery alone
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Yunfei Yuan, MD.
role: Principal Investigator
affiliation: Sun Yat-sen University
last name: Jiliang Qiu, MD.
phone: 862087343114
email: qiujl@sysucc.org.cn
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Yunfei Yuan
investigator title: Professor
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular
sharing ipd: No