<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/NCT03295006</url>
  </required_header>
  <id_info>
    <org_study_id>BTG-007961</org_study_id>
    <nct_id>NCT03295006</nct_id>
  </id_info>
  <brief_title>A TheraSphere® Advanced Dosimetry Retrospective Global Study in HCC</brief_title>
  <acronym>TARGET</acronym>
  <official_title>A TheraSphere® Advanced Dosimetry Retrospective Global Study Evaluation in Hepatocellular Carcinoma Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Scientific Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Biocompatibles UK Ltd</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Boston Scientific Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This retrospective, multinational, single-arm study will be conducted in at least 8 sites. An&#xD;
      interim analysis will be conducted with data from 100 patients with up to 10 well defined HCC&#xD;
      tumor(s) and with at least one tumor ≥3 cm. Normal tissue absorbed dose using pre-procedural&#xD;
      99mTc MAA SPECT or SPECT/CT imaging will be measured to allow the mean absorbed normal tissue&#xD;
      dose corresponding to a ≤15% probability of CTCAE grade 3 or higher hyperbilirubinemia (in&#xD;
      the absence of disease progression) to be calculated. Total bilirubin will be recorded and&#xD;
      graded according to CTCAE version 4.02. All dose-related SAEs at 3 months follow-up will be&#xD;
      followed until resolution, death or lost-to-follow-up. AEs related to disease progression&#xD;
      will not be considered related to TheraSphere.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Recently published evidence indicates a correlation between yttrium-90 dose delivered to the&#xD;
      tumor and normal tissue with safety and efficacy outcomes but there are no validated methods&#xD;
      to consistently measure dose delivered to the tumor and normal tissue. In contrast to the&#xD;
      standard clinical approach based on average dose to one target volume, this trial, sponsored&#xD;
      by Biocompatibles UK, will explore an alternative two-compartment TheraSphere dosimetry&#xD;
      methodology to calculate absorbed dose to tumor and normal tissue&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 31, 2016</start_date>
  <completion_date type="Actual">December 1, 2020</completion_date>
  <primary_completion_date type="Actual">December 1, 2020</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>Alternative two-compartment TheraSphere dosimetry methodology</measure>
    <time_frame>Baseline</time_frame>
    <description>Normal tissue absorbed dose using pre-procedural 99mTc MAA (Technetium-99m Macroaggregated albumin) SPECT (Single-photon emission computer tomography) or SPECT/CT (Single-photon emission computer tomography/Computer Tomography) imaging, to allow the mean absorbed normal tissue dose corresponding to a ≤15% probability of Common Toxicities Criteria for Adverse Events (CTCAE) grade 3 or higher hyperbilirubinemia (in the absence of disease progression) to be calculated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tumor dose</measure>
    <time_frame>Baseline</time_frame>
    <description>Tumor dose (to tumors ≥3 cm) using pre-procedural 99mTc MAA SPECT or SPECT/CT imaging.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serious adverse events</measure>
    <time_frame>3 months</time_frame>
    <description>All serious adverse events (SAEs) assessed as related or potentially related to TheraSphere</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Specific non-serious adverse events (AEs) assessed as related or potentially related to the dose of TheraSphere</measure>
    <time_frame>3 months</time_frame>
    <description>Specific non-serious adverse events (AEs) assessed as related or potentially related to the dose of TheraSphere, comprising of any of the following events:&#xD;
Hyperbilirubinemia&#xD;
Ascites&#xD;
Pain&#xD;
Fatigue&#xD;
Nausea</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical laboratory assessments</measure>
    <time_frame>6 weeks and 3 months</time_frame>
    <description>Clinical laboratory assessments</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective response (OR) of the target lesion and non-target sesions</measure>
    <time_frame>3 months and 6 months</time_frame>
    <description>Objective response (OR) of the target lesion (single largest lesion) and non-target lesion(s) at 3 months and 6 months (if available), and for all scans up to 400 days after TheraSphere administration by Modified Response Evaluation Criteria in Solid Tumors (mRECIST) and Response Evaluation Criteria in Solid Tumors (RECIST) 1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume changes</measure>
    <time_frame>3 and 6 months</time_frame>
    <description>Volume changes (i.e., perfused liver volume and non-perfused liver volume) from baseline afterTheraSphere administration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>6 months</time_frame>
    <description>Overall Survival (OS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target Alpha fetoprotein (AFP) response</measure>
    <time_frame>6 weeks and 3 months</time_frame>
    <description>Target Alpha fetoprotein (AFP) response (defined as a ≥50% decrease in AFP levels for patients with a baseline AFP level of&#xD;
≥200 ng/mL).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Albumin-bilirubin (ALBI) score</measure>
    <time_frame>6 weeks and 3 months</time_frame>
    <description>Albumin-bilirubin (ALBI) score, a measure of liver function for HCC patients after TheraSphere administration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dose to Portal Vein Thrombosis (PVT)</measure>
    <time_frame>baseline, 90 days, 180 days</time_frame>
    <description>Dose to Portal Vein Thrombosis (PVT) based upon pre- and postprocedure imaging (if PVT present).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dosimetric analysis time</measure>
    <time_frame>baseline</time_frame>
    <description>Dosimetric analysis time (i.e., workflow).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dose accuracy</measure>
    <time_frame>baseline</time_frame>
    <description>Dose accuracy based upon phantom imaging studies.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dose reproducibility</measure>
    <time_frame>baseline</time_frame>
    <description>Measurement of inter-observer agreement based on a round robin review of the same 20 patients obtained from a minimum of 8 users (with each user at a different site) and an exploratory assessment of intra-observer agreement based on a review of 10 patients by a minimum of 8 users at least 2 weeks apart. The 10 patients for the intra-observer agreement will be a subset of the patients included in the assessment of inter-observer agreement.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Normal tissue dose and tumor dose using post-procedural PET/CT Imaging</measure>
    <time_frame>baseline</time_frame>
    <description>Normal tissue dose and tumor dose (in tumors ≥3 cm) using post-procedural yttrium-90 Positron Emission Tomography/Computed Tomography (PET/CT) imaging; collection of these endpoints will allow an assessment of the correlation with the dose determined from preprocedural 99mTc MAA SPECT or SPECT/CT imaging.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">209</enrollment>
  <condition>Hepatocellular Carcinoma</condition>
  <arm_group>
    <arm_group_label>Previous Therasphere treatment</arm_group_label>
    <description>Patients who had received TheraSphere yttrium-90 microspheres</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TheraSphere</intervention_name>
    <description>Patients who had received TheraSphere</description>
    <arm_group_label>Previous Therasphere treatment</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with up to 10 well-defined unilobar HCC tumors per lobe with at least one tumor ≥3&#xD;
        cm ± PVT.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Up to 10 well defined unilobar/bilobar HCC tumor(s) per lobe with at least one tumor&#xD;
             ≥3 cm ± PVT&#xD;
&#xD;
          -  Liver dominant disease (limited extra-hepatic metastases in the lung and/or lymph&#xD;
             nodes are permitted (up to 5 lesions in the lung, with each individual lesion ≤2cm;&#xD;
             any number of lymph node lesions with each individual lesion ≤2 cm).&#xD;
&#xD;
          -  Child Pugh stage A or B7.&#xD;
&#xD;
          -  BCLC A, B or C.&#xD;
&#xD;
          -  Must be male or female, 18 years of age or older.&#xD;
&#xD;
          -  Bilirubin ≤2 mg/dL.&#xD;
&#xD;
          -  Tumor replacement &lt;50% of total liver volume assessed by diagnostic imaging consisting&#xD;
             of multi-phase contrast enhanced CT or contrast enhanced MRI.&#xD;
&#xD;
          -  Diagnostic imaging consisting of multi-phase contrast enhanced CT or contrast enhanced&#xD;
             MRI within 3 months prior to TheraSphere® administration.&#xD;
&#xD;
          -  Infusion of 99mTc-MAA in a single arterial location sufficient to cover up to 10&#xD;
             well-defined tumors per lobe ≤ 6 weeks prior to TheraSphere® administration.&#xD;
&#xD;
          -  Patients must have received TheraSphere® in a single treatment setting in one or more&#xD;
             arterial locations sufficient to cover up to 10 well-defined tumors based on&#xD;
             angiography. Subsequent TheraSphere® treatment to the second lobe may occur at least 4&#xD;
             weeks following the initial TheraSphere® treatment.&#xD;
&#xD;
          -  For patients receiving a second TheraSphere® treatment bilirubin levels must have been&#xD;
             recorded prior to the second treatment&#xD;
&#xD;
          -  Patients must have had clinical evaluation (assessment of liver specific AEs) and&#xD;
             laboratory evaluation (at least a serum bilirubin level) at baseline.&#xD;
&#xD;
          -  Tumor(s), ≥3 cm, measurable by mRECIST and RECIST 1.1 at baseline&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior external beam radiation treatment to the liver.&#xD;
&#xD;
          -  Prior loco-regional liver directed therapy (cTACE, DEB-TACE and SIR-Spheres).&#xD;
&#xD;
          -  Prior liver transplantation.&#xD;
&#xD;
          -  Whole liver TheraSphere® treatment following prior liver resection.&#xD;
&#xD;
          -  TheraSphere administration to ≤2 segments (e.g., radiation segmentectomy).&#xD;
&#xD;
          -  Additional active therapy (TACE and treatment with SIR-Spheres) between first&#xD;
             TheraSphere treatment and 3 month (90 days) imaging.&#xD;
&#xD;
          -  Hepatic vein invasion.&#xD;
&#xD;
          -  Diagnosis of disease progression at peri-procedural imaging as compared to the&#xD;
             baseline imaging (physician's discretion).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marnix Lam, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitair Medisch Centrum Utrecht</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Riad Salem, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Etienne Garin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Eugène Marquis</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hugo de Jong, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitair Medisch Centrum Utrecht</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford University Medical Center</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305-5642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Florida College of Medicine</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610-0374</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern Memorial Hospital, Robert H Lurie Comprehensive Cancer Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611-2927</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indiana University School of Medicine</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University in St. Louis, School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Louisiana</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Texas MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030-3722</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Eugene Marquis</name>
      <address>
        <city>Rennes</city>
        <zip>44229</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Essen</name>
      <address>
        <city>Essen</city>
        <zip>45122</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foundation IRCCS Istituto Nazionale Tumori</name>
      <address>
        <city>Milan</city>
        <zip>20133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Medisch Centrum Utrecht</name>
      <address>
        <city>Utrecht</city>
        <zip>3509 GA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King Faisal Hospital</name>
      <address>
        <city>Riyad</city>
        <zip>12713</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Vaudois</name>
      <address>
        <city>Lausanne</city>
        <zip>1011</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istanbul university Istanbul medical school</name>
      <address>
        <city>Fatih</city>
        <zip>34093</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florence Nightingale</name>
      <address>
        <city>Şişli</city>
        <zip>34381</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Saudi Arabia</country>
    <country>Switzerland</country>
    <country>Turkey</country>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>June 29, 2017</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <last_update_submitted>April 19, 2021</last_update_submitted>
  <last_update_submitted_qc>April 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>TheraSphere, hepatocellular carcinoma, dosimetry</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>December 1, 2021</submitted>
    <returned>February 18, 2022</returned>
    <submitted>February 22, 2022</submitted>
    <returned>May 11, 2022</returned>
    <submitted>May 18, 2022</submitted>
    <returned>February 22, 2023</returned>
    <submitted>March 16, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03295006
org study id: BTG-007961
nct id: NCT03295006
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This retrospective, multinational, single-arm study will be conducted in at least 8 sites. An
      interim analysis will be conducted with data from 100 patients with up to 10 well defined HCC
      tumor(s) and with at least one tumor ≥3 cm. Normal tissue absorbed dose using pre-procedural
      99mTc MAA SPECT or SPECT/CT imaging will be measured to allow the mean absorbed normal tissue
      dose corresponding to a ≤15% probability of CTCAE grade 3 or higher hyperbilirubinemia (in
      the absence of disease progression) to be calculated. Total bilirubin will be recorded and
      graded according to CTCAE version 4.02. All dose-related SAEs at 3 months follow-up will be
      followed until resolution, death or lost-to-follow-up. AEs related to disease progression
      will not be considered related to TheraSphere.
Recently published evidence indicates a correlation between yttrium-90 dose delivered to the
      tumor and normal tissue with safety and efficacy outcomes but there are no validated methods
      to consistently measure dose delivered to the tumor and normal tissue. In contrast to the
      standard clinical approach based on average dose to one target volume, this trial, sponsored
      by Biocompatibles UK, will explore an alternative two-compartment TheraSphere dosimetry
      methodology to calculate absorbed dose to tumor and normal tissue
observational model: Cohort
time perspective: Retrospective
measure: Alternative two-compartment TheraSphere dosimetry methodology
time frame: Baseline
description: Normal tissue absorbed dose using pre-procedural 99mTc MAA (Technetium-99m Macroaggregated albumin) SPECT (Single-photon emission computer tomography) or SPECT/CT (Single-photon emission computer tomography/Computer Tomography) imaging, to allow the mean absorbed normal tissue dose corresponding to a ≤15% probability of Common Toxicities Criteria for Adverse Events (CTCAE) grade 3 or higher hyperbilirubinemia (in the absence of disease progression) to be calculated.
measure: Tumor dose
time frame: Baseline
description: Tumor dose (to tumors ≥3 cm) using pre-procedural 99mTc MAA SPECT or SPECT/CT imaging.
measure: Serious adverse events
time frame: 3 months
description: All serious adverse events (SAEs) assessed as related or potentially related to TheraSphere
measure: Specific non-serious adverse events (AEs) assessed as related or potentially related to the dose of TheraSphere
time frame: 3 months
description: Specific non-serious adverse events (AEs) assessed as related or potentially related to the dose of TheraSphere, comprising of any of the following events:
Hyperbilirubinemia
Ascites
Pain
Fatigue
Nausea
measure: Clinical laboratory assessments
time frame: 6 weeks and 3 months
description: Clinical laboratory assessments
measure: Objective response (OR) of the target lesion and non-target sesions
time frame: 3 months and 6 months
description: Objective response (OR) of the target lesion (single largest lesion) and non-target lesion(s) at 3 months and 6 months (if available), and for all scans up to 400 days after TheraSphere administration by Modified Response Evaluation Criteria in Solid Tumors (mRECIST) and Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
measure: Volume changes
time frame: 3 and 6 months
description: Volume changes (i.e., perfused liver volume and non-perfused liver volume) from baseline afterTheraSphere administration.
measure: Overall Survival (OS)
time frame: 6 months
description: Overall Survival (OS)
measure: Target Alpha fetoprotein (AFP) response
time frame: 6 weeks and 3 months
description: Target Alpha fetoprotein (AFP) response (defined as a ≥50% decrease in AFP levels for patients with a baseline AFP level of
≥200 ng/mL).
measure: Albumin-bilirubin (ALBI) score
time frame: 6 weeks and 3 months
description: Albumin-bilirubin (ALBI) score, a measure of liver function for HCC patients after TheraSphere administration.
measure: Dose to Portal Vein Thrombosis (PVT)
time frame: baseline, 90 days, 180 days
description: Dose to Portal Vein Thrombosis (PVT) based upon pre- and postprocedure imaging (if PVT present).
measure: Dosimetric analysis time
time frame: baseline
description: Dosimetric analysis time (i.e., workflow).
measure: Dose accuracy
time frame: baseline
description: Dose accuracy based upon phantom imaging studies.
measure: Dose reproducibility
time frame: baseline
description: Measurement of inter-observer agreement based on a round robin review of the same 20 patients obtained from a minimum of 8 users (with each user at a different site) and an exploratory assessment of intra-observer agreement based on a review of 10 patients by a minimum of 8 users at least 2 weeks apart. The 10 patients for the intra-observer agreement will be a subset of the patients included in the assessment of inter-observer agreement.
measure: Normal tissue dose and tumor dose using post-procedural PET/CT Imaging
time frame: baseline
description: Normal tissue dose and tumor dose (in tumors ≥3 cm) using post-procedural yttrium-90 Positron Emission Tomography/Computed Tomography (PET/CT) imaging; collection of these endpoints will allow an assessment of the correlation with the dose determined from preprocedural 99mTc MAA SPECT or SPECT/CT imaging.
arm group label: Previous Therasphere treatment
description: Patients who had received TheraSphere yttrium-90 microspheres
intervention type: Device
intervention name: TheraSphere
description: Patients who had received TheraSphere
arm group label: Previous Therasphere treatment
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marnix Lam, MD, PhD
role: Principal Investigator
affiliation: Universitair Medisch Centrum Utrecht
last name: Riad Salem, MD
role: Principal Investigator
affiliation: Northwestern University
last name: Etienne Garin, MD
role: Principal Investigator
affiliation: Centre Eugène Marquis
last name: Hugo de Jong, PhD
role: Principal Investigator
affiliation: Universitair Medisch Centrum Utrecht
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
country: Germany
country: Italy
country: Netherlands
country: Saudi Arabia
country: Switzerland
country: Turkey
country: United States
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular
sharing ipd: No
submitted: December 1, 2021
returned: February 18, 2022
submitted: February 22, 2022
returned: May 11, 2022
submitted: May 18, 2022
returned: February 22, 2023
submitted: March 16, 2023