<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/NCT03780049</url>
  </required_header>
  <id_info>
    <org_study_id>HCC-S032</org_study_id>
    <nct_id>NCT03780049</nct_id>
  </id_info>
  <brief_title>HAIC Plus H101 vs HAIC Alone for Unresectable HCC at BCLC A-B</brief_title>
  <official_title>Hepatic Artery Infusion Chemotherapy Plus Recombinant Human Type-5 Adenovirus vs Hepatic Artery Infusion Chemotherapy Alone for Unresectable Hepatocellular Carcinoma at Barcelona Clinic Liver Cancer A-B Stage</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>
    <has_dmc>Yes</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>
      Hepatic artery infusion chemotherapy (HAIC) is effective and safe for hepatocellular&#xD;
      carcinoma (HCC). Recombinant Human Type-5 Adenovirus (H101) is safe for HCC. The purpose of&#xD;
      this study is to evaluate the efficacy and safety of HAIC combined with H101 compared with&#xD;
      HAIC alone in patients with unresectable hepatocellular carcinoma (HCC) at barcelona clinic&#xD;
      liver cancer A-B stage.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Anticipated">October 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2023</primary_completion_date>
  <phase>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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>24 months</time_frame>
    <description>OS was defined as the duration from the date of randomization until the date of death from any cause. Participants who were lost to follow-up were censored at the last date the participant was known to be alive, and participants who remained alive were censored at the time of data cutoff.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression free survival (PFS)</measure>
    <time_frame>24 months</time_frame>
    <description>PFS was defined as the time from the date of randomization to the date of first documentation of disease progression based on modified Response Evaluation Criteria in Solid Tumors (mRECIST), or date of death, whichever occurred first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of adverse events</measure>
    <time_frame>30 days</time_frame>
    <description>Postoperative adverse events were graded based on CTCAE v4.03</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Conversion rate to resection</measure>
    <time_frame>24 months</time_frame>
    <description>Patients receive subsequent resection.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">304</enrollment>
  <condition>Hepatocellular Carcinoma</condition>
  <arm_group>
    <arm_group_label>HAIC plus H101</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive oxaliplatin, 5-fluorouracil and leucovorin and recombinant human type-5 adenovirus 0.5ml via hepatic artery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HAIC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients receive oxaliplatin, 5-fluorouracil and leucovorin and normal saline via hepatic artery</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>HAIC of FOLFOX</intervention_name>
    <description>administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries</description>
    <arm_group_label>HAIC</arm_group_label>
    <arm_group_label>HAIC plus H101</arm_group_label>
    <other_name>Hepatic artery infusion chemotherapy of oxaliplatin , fluorouracil, and leucovorin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>H101</intervention_name>
    <description>Patients receive H101 0.5ml dissolved in 10ml normal saline in each session of HAIC</description>
    <arm_group_label>HAIC plus H101</arm_group_label>
    <other_name>Recombinant Human Type-5 Adenovirus</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebos</intervention_name>
    <description>Patients receive normal saline 10ml in each session of HAIC</description>
    <arm_group_label>HAIC</arm_group_label>
    <other_name>normal saline</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The diagnosis of HCC&#xD;
&#xD;
          -  Patients must have at least one tumor lesion that can be accurately measured according&#xD;
             to mRECIST criteria.&#xD;
&#xD;
          -  With no previous treatment&#xD;
&#xD;
          -  Single lesion with tumor size larger 7cm or multiple lesions&#xD;
&#xD;
          -  No Cirrhosis or cirrhotic status of Child-Pugh class A only&#xD;
&#xD;
          -  Not amendable to surgical resection ,local ablative therapy and any other cured&#xD;
             treatment.&#xD;
&#xD;
          -  BCLC A-B stage&#xD;
&#xD;
          -  The following laboratory parameters:&#xD;
&#xD;
        Platelet count ≥ 50,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥&#xD;
        32 g/L ASL and AST ≤ 6 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of&#xD;
        normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) &gt;1,500/mm3&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients complicated by history of heart disease, history of gastrointestinal bleeding&#xD;
             within 1 month, severe infection (&gt; grade 2 National Cancer Institute [NCI] -common&#xD;
             Terminology Criteria for Adverse Events [CTCAE] version 4.0) or other serious&#xD;
             associated diseases will not be able to tolerate treatment&#xD;
&#xD;
          -  With other malignant tumors&#xD;
&#xD;
          -  Known or suspected allergy to the investigational agents or any agent given in&#xD;
             association with this trial&#xD;
&#xD;
          -  History of organ allograft&#xD;
&#xD;
          -  Pregnant or lactating woman&#xD;
&#xD;
          -  patients with poor compliance&#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>Ming Shi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sun Yat-sen University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ming Shi, MD</last_name>
    <phone>+862087343938</phone>
    <email>shiming@sysucc.org.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cancer Center Sun Yat-sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510060</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ming Shi, MD</last_name>
      <phone>8620-87343115</phone>
      <email>shiming@mail.sysu.edu.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>May 19, 2020</last_update_submitted>
  <last_update_submitted_qc>May 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 21, 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>Shi Ming</investigator_full_name>
    <investigator_title>Proffessor</investigator_title>
  </responsible_party>
  <keyword>Hepatocellular Carcinoma</keyword>
  <keyword>Hepatic artery infusion chemotherapy</keyword>
  <keyword>Oxaliplatin, 5-fluorouracil and leucovorin</keyword>
  <keyword>Recombinant Human Type-5 Adenovirus</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leucovorin</mesh_term>
    <mesh_term>Fluorouracil</mesh_term>
    <mesh_term>Oxaliplatin</mesh_term>
  </intervention_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/NCT03780049
org study id: HCC-S032
nct id: NCT03780049
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Hepatic artery infusion chemotherapy (HAIC) is effective and safe for hepatocellular
      carcinoma (HCC). Recombinant Human Type-5 Adenovirus (H101) is safe for HCC. The purpose of
      this study is to evaluate the efficacy and safety of HAIC combined with H101 compared with
      HAIC alone in patients with unresectable hepatocellular carcinoma (HCC) at barcelona clinic
      liver cancer A-B stage.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Overall survival (OS)
time frame: 24 months
description: OS was defined as the duration from the date of randomization until the date of death from any cause. Participants who were lost to follow-up were censored at the last date the participant was known to be alive, and participants who remained alive were censored at the time of data cutoff.
measure: Progression free survival (PFS)
time frame: 24 months
description: PFS was defined as the time from the date of randomization to the date of first documentation of disease progression based on modified Response Evaluation Criteria in Solid Tumors (mRECIST), or date of death, whichever occurred first.
measure: Number of adverse events
time frame: 30 days
description: Postoperative adverse events were graded based on CTCAE v4.03
measure: Conversion rate to resection
time frame: 24 months
description: Patients receive subsequent resection.
arm group label: HAIC plus H101
arm group type: Experimental
description: Patients receive oxaliplatin, 5-fluorouracil and leucovorin and recombinant human type-5 adenovirus 0.5ml via hepatic artery
arm group label: HAIC
arm group type: Active Comparator
description: Patients receive oxaliplatin, 5-fluorouracil and leucovorin and normal saline via hepatic artery
intervention type: Procedure
intervention name: HAIC of FOLFOX
description: administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
arm group label: HAIC
arm group label: HAIC plus H101
other name: Hepatic artery infusion chemotherapy of oxaliplatin , fluorouracil, and leucovorin
intervention type: Drug
intervention name: H101
description: Patients receive H101 0.5ml dissolved in 10ml normal saline in each session of HAIC
arm group label: HAIC plus H101
other name: Recombinant Human Type-5 Adenovirus
intervention type: Drug
intervention name: Placebos
description: Patients receive normal saline 10ml in each session of HAIC
arm group label: HAIC
other name: normal saline
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Ming Shi, MD
role: Principal Investigator
affiliation: Sun Yat-sen University
last name: Ming Shi, MD
phone: +862087343938
email: shiming@sysucc.org.cn
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Shi Ming
investigator title: Proffessor
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular
mesh term: Leucovorin
mesh term: Fluorouracil
mesh term: Oxaliplatin