<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/NCT03009461</url>
  </required_header>
  <id_info>
    <org_study_id>MPVTT</org_study_id>
    <nct_id>NCT03009461</nct_id>
  </id_info>
  <brief_title>Sorafenib Plus Hepatic Arterial Infusion Versus Sorafenib for HCC With Major Portal Vein Tumor Thrombosis</brief_title>
  <official_title>Randomized Trial of Sorafenib Plus Hepatic Arterial Infusion With Oxaliplatin and Fluorouracil Versus Sorafenib for Hepatocellular Carcinoma With Major Portal Vein Tumor Thrombosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking 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>
      According to the Barcelona clinic liver cancer (BCLC) staging treatment guideline, sorafenib&#xD;
      is recommended for Hepatocellular Carcinoma (HCC) with Portal Vein Tumor Thrombosis (PVTT),&#xD;
      but HCC with major PVTT (in the main trunk or 1st-order branches of the portal vein) did not&#xD;
      benefit much from sorafenib in previous studies. There is no established standard treatment&#xD;
      for HCC patients with major PVTT, the investigators conducted a randomized, phase 2 study to&#xD;
      investigate the survival benefit of sorafenib plus Hepatic arterial infusion chemotherapy&#xD;
      (HAIC) with Oxaliplatin and Fluorouracil versus sorafenib for Hepatocellular Carcinoma with&#xD;
      Major Portal Vein Tumor Thrombosis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2017</start_date>
  <completion_date type="Actual">December 28, 2020</completion_date>
  <primary_completion_date type="Actual">June 15, 2020</primary_completion_date>
  <phase>Phase 2</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>Overall survival</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>HepatoCellular Carcinoma</condition>
  <condition>Portal Vein Thrombosis</condition>
  <arm_group>
    <arm_group_label>Sor-HAIC group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>400 mg of sorafenib (consisting of two 200-mg tablets) twice daily. hepatic arterial chemotherapy consisted of infusions of oxaliplatin (35 mg/m2 for 2 hours), followed by 5-fluorouracil (600 mg/m2 for 22 hours) on day1-3 every 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sor group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>400 mg of sorafenib (consisting of two 200-mg tablets) twice daily.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>HAIC</intervention_name>
    <description>Intra-arterial chemotherapy consisted of infusions of oxaliplatin (35 mg/m2 for 2 hours), followed by 5-fluorouracil (600 mg/m2 for 22 hours) on day1-3 every 4 weeks. For each cycle, leucovorin calcium 200 mg/m2 was intravenously administered for 2 hours from beginning of 5-fluorouracil infusion.</description>
    <arm_group_label>Sor-HAIC group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sorafenib</intervention_name>
    <description>400 mg of sorafenib (consisting of two 200-mg tablets) twice daily.</description>
    <arm_group_label>Sor group</arm_group_label>
    <arm_group_label>Sor-HAIC group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient must have histologically or clinically confirmed hepatocellular carcinoma.&#xD;
&#xD;
          -  HCC with major PVTT (in the main trunk or 1st-order branches of the portal vein)&#xD;
&#xD;
          -  Child A class&#xD;
&#xD;
          -  Patient's Eastern Cooperative Oncology Group (ECOG) performance status must be =&lt; 2&#xD;
             (Karnofsky &gt;= 60%)&#xD;
&#xD;
          -  Absolute neutrophil count &gt;= 1,500/mcL&#xD;
&#xD;
          -  Platelets &gt;= 100,000/mcL&#xD;
&#xD;
          -  Hemoglobin &gt;= 90g/L&#xD;
&#xD;
          -  Total bilirubin =&lt; 2 X institutional upper limit of normal&#xD;
&#xD;
          -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase&#xD;
             [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT])&#xD;
             =&lt; 2.5 X institutional upper limit of normality&#xD;
&#xD;
          -  Creatinine =&lt; 1.5 X institutional upper limit of normal&#xD;
&#xD;
          -  Albumin &gt;= 30g/L&#xD;
&#xD;
          -  Patient must be able to understand and willing to sign a written informed consent&#xD;
             document&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have had prior chemotherapy with Oxaliplatin or Fluorouracil or&#xD;
             sorafenib.&#xD;
&#xD;
          -  Patient who is receiving any other investigational agents&#xD;
&#xD;
          -  Patient who have a diagnosis of hepatic encephalopathy&#xD;
&#xD;
          -  Patients who have a diagnosis of sclerosing cholangitis.&#xD;
&#xD;
          -  Patients who have a diagnosis of Gilbert's disease.&#xD;
&#xD;
          -  Patients who have clinical ascites&#xD;
&#xD;
          -  Patient must not have any uncontrolled concurrent illness including, but not limited&#xD;
             to, ongoing or active infection, symptomatic congestive heart failure, unstable angina&#xD;
             pectoris, cardiac arrhythmia, uncontrolled diabetes mellitus and hypertension, or&#xD;
             psychiatric illness/social situations that would limit compliance with study&#xD;
             requirements&#xD;
&#xD;
          -  No other malignancy except localized basal cell or squamous cell skin cancer in the&#xD;
             past 5 years&#xD;
&#xD;
          -  Patient who is pregnant or lactating&#xD;
&#xD;
          -  Patient Allergic to Iodine contrast medium&#xD;
&#xD;
          -  Uncontrolled severe coagulation disorders (INR &lt; 1.5 in patients not on warfarin&#xD;
             therapy)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Peking University Cancer Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100142</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>January 2, 2017</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>October 8, 2021</last_update_submitted>
  <last_update_submitted_qc>October 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University</investigator_affiliation>
    <investigator_full_name>Xiaodong Wang, MD</investigator_full_name>
    <investigator_title>Chief Physician, Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Hepatocellular carcinoma</keyword>
  <keyword>Portal vein tumor thrombosis</keyword>
  <keyword>Hepatic arterial infusion chemotherapy</keyword>
  <keyword>Sorafenib</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>
    <mesh_term>Thrombosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sorafenib</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/NCT03009461
org study id: MPVTT
nct id: NCT03009461
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
According to the Barcelona clinic liver cancer (BCLC) staging treatment guideline, sorafenib
      is recommended for Hepatocellular Carcinoma (HCC) with Portal Vein Tumor Thrombosis (PVTT),
      but HCC with major PVTT (in the main trunk or 1st-order branches of the portal vein) did not
      benefit much from sorafenib in previous studies. There is no established standard treatment
      for HCC patients with major PVTT, the investigators conducted a randomized, phase 2 study to
      investigate the survival benefit of sorafenib plus Hepatic arterial infusion chemotherapy
      (HAIC) with Oxaliplatin and Fluorouracil versus sorafenib for Hepatocellular Carcinoma with
      Major Portal Vein Tumor Thrombosis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall survival
time frame: 1 year
arm group label: Sor-HAIC group
arm group type: Experimental
description: 400 mg of sorafenib (consisting of two 200-mg tablets) twice daily. hepatic arterial chemotherapy consisted of infusions of oxaliplatin (35 mg/m2 for 2 hours), followed by 5-fluorouracil (600 mg/m2 for 22 hours) on day1-3 every 4 weeks.
arm group label: Sor group
arm group type: Active Comparator
description: 400 mg of sorafenib (consisting of two 200-mg tablets) twice daily.
intervention type: Procedure
intervention name: HAIC
description: Intra-arterial chemotherapy consisted of infusions of oxaliplatin (35 mg/m2 for 2 hours), followed by 5-fluorouracil (600 mg/m2 for 22 hours) on day1-3 every 4 weeks. For each cycle, leucovorin calcium 200 mg/m2 was intravenously administered for 2 hours from beginning of 5-fluorouracil infusion.
arm group label: Sor-HAIC group
intervention type: Drug
intervention name: Sorafenib
description: 400 mg of sorafenib (consisting of two 200-mg tablets) twice daily.
arm group label: Sor group
arm group label: Sor-HAIC group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking University
investigator full name: Xiaodong Wang, MD
investigator title: Chief Physician, Associate Professor
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular
mesh term: Thrombosis
mesh term: Sorafenib