<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/NCT02981498</url>
  </required_header>
  <id_info>
    <org_study_id>HCC-S027</org_study_id>
    <nct_id>NCT02981498</nct_id>
  </id_info>
  <brief_title>Phase II Trial of Sorafenib Combined With Concurrent HAIC for Hepatocellular Carcinoma</brief_title>
  <official_title>Phase II Trial of Sorafenib Combined With Concurrent Hepatic Arterial Infusion (HAI) of Oxaliplatin, 5-fluorouracil and Leucovorin for Hepatocellular Carcinoma</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate safety and efficacy of combined hepatic arterial infusion (HAIC) of oxaliplatin,&#xD;
      5-fluorouracil and leucovorin and sorafenib in patients with advanced hepatocellular&#xD;
      carcinoma (HCC).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In most current guidelines, unresectable HCC with major PVTT are considered not generally&#xD;
      suitable for transarterial chemoembolization, and sorafenib is recommended as standard&#xD;
      care.3-5 However, for patients with major PVTT, the median overall survival of those treated&#xD;
      with sorafenib monotherapy was only 3.1 to 6.0 months.&#xD;
&#xD;
      Whether combining sorafenib with hepatic arterial infusion (HAIC) of oxaliplatin,&#xD;
      5-fluorouracil and leucovorin is safe, well tolerated, and efficacious remains unknown, with&#xD;
      no prospective clinical data currently available.The investigators therefore conducted a&#xD;
      prospective single center, single-arm phase II trial to evaluate the safety and efficacy of&#xD;
      sorafenib combined with HAIC in patients with unresectable advanced HCC.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2015</start_date>
  <completion_date type="Actual">April 2017</completion_date>
  <primary_completion_date type="Actual">April 2017</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>progression-free survival rate</measure>
    <time_frame>3 month</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective response</measure>
    <time_frame>3 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OS</measure>
    <time_frame>12 months</time_frame>
    <description>Overall Survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AE event</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">35</enrollment>
  <condition>Hepatocellular Carcinoma</condition>
  <arm_group>
    <arm_group_label>Sorafenib combined with HAIC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sorafenib combined with Hepatic arterial infusion chemotherapy with Folfox Protocol</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Hepatic arterial infusion chemotherapy</intervention_name>
    <description>administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries</description>
    <arm_group_label>Sorafenib combined with HAIC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Folfox Protocol</intervention_name>
    <description>Oxaliplatin , fluorouracil, and leucovorin</description>
    <arm_group_label>Sorafenib combined with HAIC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Criteria:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European&#xD;
             Association for the Study of the Liver (EASL)&#xD;
&#xD;
          -  Patients must have at least one tumor lesion that can be accurately measured according&#xD;
             to EASL criteria.&#xD;
&#xD;
          -  diagnosed with major or main portal vein invasion (Vp3 or Vp4)&#xD;
&#xD;
          -  KPS≥70；&#xD;
&#xD;
          -  with no previous treatment&#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;
          -  The following laboratory parameters:&#xD;
&#xD;
               -  Platelet count ≥ 75,000/µL&#xD;
&#xD;
               -  Hemoglobin ≥ 8.5 g/dL&#xD;
&#xD;
               -  Total bilirubin ≤ 30mmol/L&#xD;
&#xD;
               -  Serum albumin ≥ 30 g/L&#xD;
&#xD;
               -  ASL and AST ≤ 5 x upper limit of normal&#xD;
&#xD;
               -  Serum creatinine ≤ 1.5 x upper limit of normal&#xD;
&#xD;
               -  INR ≤ 1.5 or PT/APTT within normal limits&#xD;
&#xD;
               -  Absolute neutrophil count (ANC) &gt;1,500/mm3&#xD;
&#xD;
          -  Ability to understand the protocol and to agree to and sign a written informed consent&#xD;
             document&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or&#xD;
             hepatic encephalopathy&#xD;
&#xD;
          -  Known history of HIV&#xD;
&#xD;
          -  History of organ allograft&#xD;
&#xD;
          -  Known or suspected allergy to the investigational agents or any agent given in&#xD;
             association with this trial.&#xD;
&#xD;
          -  Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy&#xD;
&#xD;
          -  Evidence of bleeding diathesis.&#xD;
&#xD;
          -  Patients with clinically significant gastrointestinal bleeding within 30 days prior to&#xD;
             study entry.&#xD;
&#xD;
          -  Any other hemorrhage/bleeding event &gt; CTCAE Grade 3 within 4 weeks of first dose of&#xD;
             study drug&#xD;
&#xD;
          -  Serious non-healing wound, ulcer, or bone fracture&#xD;
&#xD;
          -  Known central nervous system tumors including metastatic brain disease&#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>The Department of Hepatobiliary Oncology of Sun Yat-sen University Cancer Center</affiliation>
  </overall_official>
  <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>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Llovet JM, Real MI, Montana X, Planas R, Coll S, Aponte J, Ayuso C, Sala M, Muchart J, Sola R, Rodes J, Bruix J; Barcelona Liver Cancer Group. Arterial embolisation or chemoembolisation versus symptomatic treatment in patients with unresectable hepatocellular carcinoma: a randomised controlled trial. Lancet. 2002 May 18;359(9319):1734-9. doi: 10.1016/S0140-6736(02)08649-X.</citation>
    <PMID>12049862</PMID>
  </results_reference>
  <results_reference>
    <citation>Ando E, Yamashita F, Tanaka M, Tanikawa K. A novel chemotherapy for advanced hepatocellular carcinoma with tumor thrombosis of the main trunk of the portal vein. Cancer. 1997 May 15;79(10):1890-6. doi: 10.1002/(sici)1097-0142(19970515)79:103.0.co;2-k.</citation>
    <PMID>9149014</PMID>
  </results_reference>
  <results_reference>
    <citation>Luo J, Guo RP, Lai EC, Zhang YJ, Lau WY, Chen MS, Shi M. Transarterial chemoembolization for unresectable hepatocellular carcinoma with portal vein tumor thrombosis: a prospective comparative study. Ann Surg Oncol. 2011 Feb;18(2):413-20. doi: 10.1245/s10434-010-1321-8. Epub 2010 Sep 14.</citation>
    <PMID>20839057</PMID>
  </results_reference>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>March 5, 2019</last_update_submitted>
  <last_update_submitted_qc>March 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 6, 2019</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>Proffesor</investigator_title>
  </responsible_party>
  <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>
  </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/NCT02981498
org study id: HCC-S027
nct id: NCT02981498
lead sponsor: 
has dmc: Yes
To evaluate safety and efficacy of combined hepatic arterial infusion (HAIC) of oxaliplatin,
      5-fluorouracil and leucovorin and sorafenib in patients with advanced hepatocellular
      carcinoma (HCC).
In most current guidelines, unresectable HCC with major PVTT are considered not generally
      suitable for transarterial chemoembolization, and sorafenib is recommended as standard
      care.3-5 However, for patients with major PVTT, the median overall survival of those treated
      with sorafenib monotherapy was only 3.1 to 6.0 months.

      Whether combining sorafenib with hepatic arterial infusion (HAIC) of oxaliplatin,
      5-fluorouracil and leucovorin is safe, well tolerated, and efficacious remains unknown, with
      no prospective clinical data currently available.The investigators therefore conducted a
      prospective single center, single-arm phase II trial to evaluate the safety and efficacy of
      sorafenib combined with HAIC in patients with unresectable advanced HCC.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: progression-free survival rate
time frame: 3 month
measure: Objective response
time frame: 3 month
measure: OS
time frame: 12 months
description: Overall Survival
measure: AE event
time frame: 3 months
arm group label: Sorafenib combined with HAIC
arm group type: Experimental
description: Sorafenib combined with Hepatic arterial infusion chemotherapy with Folfox Protocol
intervention type: Procedure
intervention name: Hepatic arterial infusion chemotherapy
description: administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
arm group label: Sorafenib combined with HAIC
intervention type: Drug
intervention name: Folfox Protocol
description: Oxaliplatin , fluorouracil, and leucovorin
arm group label: Sorafenib combined with HAIC
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Ming Shi, MD
role: Principal Investigator
affiliation: The Department of Hepatobiliary Oncology of Sun Yat-sen University Cancer Center
facility: 
country: China
citation: Llovet JM, Real MI, Montana X, Planas R, Coll S, Aponte J, Ayuso C, Sala M, Muchart J, Sola R, Rodes J, Bruix J; Barcelona Liver Cancer Group. Arterial embolisation or chemoembolisation versus symptomatic treatment in patients with unresectable hepatocellular carcinoma: a randomised controlled trial. Lancet. 2002 May 18;359(9319):1734-9. doi: 10.1016/S0140-6736(02)08649-X.
PMID: 12049862
citation: Ando E, Yamashita F, Tanaka M, Tanikawa K. A novel chemotherapy for advanced hepatocellular carcinoma with tumor thrombosis of the main trunk of the portal vein. Cancer. 1997 May 15;79(10):1890-6. doi: 10.1002/(sici)1097-0142(19970515)79:103.0.co;2-k.
PMID: 9149014
citation: Luo J, Guo RP, Lai EC, Zhang YJ, Lau WY, Chen MS, Shi M. Transarterial chemoembolization for unresectable hepatocellular carcinoma with portal vein tumor thrombosis: a prospective comparative study. Ann Surg Oncol. 2011 Feb;18(2):413-20. doi: 10.1245/s10434-010-1321-8. Epub 2010 Sep 14.
PMID: 20839057
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Shi Ming
investigator title: Proffesor
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular
sharing ipd: No