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/NCT06024252</url>
    </required_header>
    <id_info>
      <org_study_id>CHANCE023</org_study_id>
      <nct_id>NCT06024252</nct_id>
    </id_info>
    <brief_title>Efficacy, Safety, and Treatment Patterns of Transcatheter Arterial Chemoembolization (TACE) Combined With Atezolizumab and Bevacizumab in Unresectable Hepatocellular Carcinoma: a Multicenter, Retrospective, Observational Real-world Study</brief_title>
    <acronym>CHANCE023</acronym>
    <official_title>Efficacy, Safety, and Treatment Patterns of Transcatheter Arterial Chemoembolization (TACE) Combined With Atezolizumab and Bevacizumab in Unresectable Hepatocellular Carcinoma: a Multicenter, Retrospective, Observational Real-world Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Zhongda Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Zhongda Hospital</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>
        This study will evaluate the efficacy and safety of TACE combined with atezolizumab +&#xD;
        bevacizumab in the treatment of unresectable hepatocellular carcinoma, and the treatment&#xD;
        patterns of the combination regimen&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is a multi-center, retrospective and observational real-world study to explore the&#xD;
        efficacy, safety and treatment pattern of TACE combined with Atezolizumab + Bevacizumab in&#xD;
        unresectable hepatocellular carcinoma. The target population for the planned retrospective&#xD;
        analysis of this project is patients who have been diagnosed with unresectable HCC according&#xD;
        to the guidelines for Diagnosis and Treatment of Primary Liver Cancer in China (2019 Edition)&#xD;
        and treated with TACE combined with atezolizumab + bevacizumab.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">June 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 1, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Overall survival</measure>
      <time_frame>1 year</time_frame>
      <description>Overall survival (OS): defined as the time from the start of the first TACE or atezolizumab + bevacizumab (whichever occurs first) to death due to any cause.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Progression-Free Survival</measure>
      <time_frame>1 year</time_frame>
      <description>Progression-Free Survival (PFS): defined as the time from the start of the first TACE or atezolizumab + bevacizumab (whichever occurs first) to the first occurrence of disease progression or death from any cause.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Objective response rate</measure>
      <time_frame>1 year</time_frame>
      <description>Objective response rate (ORR): defined as the percentage of patients with objective response (CR and PR) from the start of treatment until tumor progression.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>One-year survival rate</measure>
      <time_frame>1 year</time_frame>
      <description>One-year survival rate: defined as the percentage of patients who are survival for 1 year from the start of this treatment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Immune-TACE PFS</measure>
      <time_frame>1 year</time_frame>
      <description>Immune-TACE PFS: defined as the time from the first TACE or atezolizumab bevacizumab (whichever occurs first) to the occurrence of one of the following events (whichever occurs first):&#xD;
  20% enlargement of intra- or extra-hepatic lesions as assessed by mRECIST or appearance of new extra-hepatic lesions;&#xD;
  TACE refractoriness: insufficient tumor response in the treated tumor for three consecutive times (20% increase by mRECIST);&#xD;
  Deterioration of macrovascular invasion (MVI, defined as tumor invasion of the portal vein or hepatic vein and its branches);&#xD;
  Deterioration of liver function to Child-Pugh C or mALBI 2b;&#xD;
  Death from any cause.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease control rate</measure>
      <time_frame>1 year</time_frame>
      <description>Disease control rate (DCR): defined as the proportion of patients achieving complete response (CR) or partial response (PR) or stable disease (SD).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Treatment pattern</measure>
      <time_frame>1 year</time_frame>
      <description>Treatment pattern: including the timing and frequency of TACE (including its matching chemotherapy regimen), the treatment regimen of atezolizumab + bevacizumab, the sequence of combination therapy and the treatment regimen of the latter line.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">200</enrollment>
    <condition>HCC</condition>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>TACE</intervention_name>
      <description>TACE in combination with atezolizumab + bevacizumab for at least one interval of no more than eight weeks.</description>
      <other_name>Atezolizumab</other_name>
      <other_name>Bevacizumab</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The target population for the planned retrospective analysis of this project is patients&#xD;
          who have been diagnosed with unresectable HCC according to the guidelines for Diagnosis and&#xD;
          Treatment of Primary Liver Cancer in China (2019 Edition) and treated with TACE combined&#xD;
          with atezolizumab + bevacizumab.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. All patients were diagnosed with unresectable hepatocellular carcinoma according to&#xD;
               the guidelines for Diagnosis and Treatment of Primary Liver Cancer in China (2019&#xD;
               Edition);&#xD;
  &#xD;
            2. Patients ≥ 18 years old, male or female;&#xD;
  &#xD;
            3. Child-Pugh Class A and B liver function;&#xD;
  &#xD;
            4. ECOG-PS score of 0 ~ 2 points;&#xD;
  &#xD;
            5. Received TACE in combination with atezolizumab + bevacizumab for at least one interval&#xD;
               of no more than eight weeks.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Other primary malignancies;&#xD;
  &#xD;
            2. Incomplete data, such as no baseline image that can be assessed according to RECIST&#xD;
               1.1 or mRECIST, and survival outcome.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Gao-Jun Teng, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Zhongda Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jian Lu, MD</last_name>
      <phone>+86 5850654644</phone>
      <email>lujian43307131@126.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Zhongda Hospital</investigator_affiliation>
      <investigator_full_name>Gao-jun Teng</investigator_full_name>
      <investigator_title>Dr. Gao-Jun Teng</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carcinoma, Hepatocellular</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Atezolizumab</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06024252
  org study id: CHANCE023
  nct id: NCT06024252
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study will evaluate the efficacy and safety of TACE combined with atezolizumab +
        bevacizumab in the treatment of unresectable hepatocellular carcinoma, and the treatment
        patterns of the combination regimen
  This study is a multi-center, retrospective and observational real-world study to explore the
        efficacy, safety and treatment pattern of TACE combined with Atezolizumab + Bevacizumab in
        unresectable hepatocellular carcinoma. The target population for the planned retrospective
        analysis of this project is patients who have been diagnosed with unresectable HCC according
        to the guidelines for Diagnosis and Treatment of Primary Liver Cancer in China (2019 Edition)
        and treated with TACE combined with atezolizumab + bevacizumab.
  observational model: Cohort
  time perspective: Retrospective
  measure: Overall survival
  time frame: 1 year
  description: Overall survival (OS): defined as the time from the start of the first TACE or atezolizumab + bevacizumab (whichever occurs first) to death due to any cause.
  measure: Progression-Free Survival
  time frame: 1 year
  description: Progression-Free Survival (PFS): defined as the time from the start of the first TACE or atezolizumab + bevacizumab (whichever occurs first) to the first occurrence of disease progression or death from any cause.
  measure: Objective response rate
  time frame: 1 year
  description: Objective response rate (ORR): defined as the percentage of patients with objective response (CR and PR) from the start of treatment until tumor progression.
  measure: One-year survival rate
  time frame: 1 year
  description: One-year survival rate: defined as the percentage of patients who are survival for 1 year from the start of this treatment.
  measure: Immune-TACE PFS
  time frame: 1 year
  description: Immune-TACE PFS: defined as the time from the first TACE or atezolizumab bevacizumab (whichever occurs first) to the occurrence of one of the following events (whichever occurs first):
  20% enlargement of intra- or extra-hepatic lesions as assessed by mRECIST or appearance of new extra-hepatic lesions;
  TACE refractoriness: insufficient tumor response in the treated tumor for three consecutive times (20% increase by mRECIST);
  Deterioration of macrovascular invasion (MVI, defined as tumor invasion of the portal vein or hepatic vein and its branches);
  Deterioration of liver function to Child-Pugh C or mALBI 2b;
  Death from any cause.
  measure: Disease control rate
  time frame: 1 year
  description: Disease control rate (DCR): defined as the proportion of patients achieving complete response (CR) or partial response (PR) or stable disease (SD).
  measure: Treatment pattern
  time frame: 1 year
  description: Treatment pattern: including the timing and frequency of TACE (including its matching chemotherapy regimen), the treatment regimen of atezolizumab + bevacizumab, the sequence of combination therapy and the treatment regimen of the latter line.
  intervention type: Drug
  intervention name: TACE
  description: TACE in combination with atezolizumab + bevacizumab for at least one interval of no more than eight weeks.
  other name: Atezolizumab
  other name: Bevacizumab
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  last name: Gao-Jun Teng, MD
  role: Principal Investigator
  affiliation: Zhongda Hospital
  last name: Jian Lu, MD
  phone: +86 5850654644
  email: lujian43307131@126.com
  responsible party type: Principal Investigator
  investigator affiliation: Zhongda Hospital
  investigator full name: Gao-jun Teng
  investigator title: Dr. Gao-Jun Teng
  mesh term: Carcinoma, Hepatocellular
  mesh term: Atezolizumab
  sharing ipd: Undecided