<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/NCT02987699</url>
  </required_header>
  <id_info>
    <org_study_id>Unique Protocol ID: HCC-S026</org_study_id>
    <nct_id>NCT02987699</nct_id>
  </id_info>
  <brief_title>Phase II Study of HAIC Using Cisplatin,Leucovorin and 5-Fluorouracil</brief_title>
  <official_title>Phase II Study of Hepatic Arterial Infusion Chemotherapy Using Oxaliplatin,Leucovorin and 5-Fluorouracil</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>
      The purpose of this phase II study is to determine the recommended dose, as well as the&#xD;
      safety and efficacy of the combination of oxaliplatin, leucovorin and 5-Fu introduced by&#xD;
      hepatic arterial infusion chemotherapy (HAIC) in patients with advanced hepatocellular&#xD;
      carcinoma (HCC).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The results of our preliminary pilot study suggested that the combination of oxaliplatin,&#xD;
      leucovorin and 5-Fu introduced by hepatic arterial infusion chemotherapy (HAIC) may improve&#xD;
      the survivals for advanced stage HCC. Thus, the investigators carried out this prospective&#xD;
      randomized control study to determine the recommended dose as well as the safety and&#xD;
      efficacy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">May 2017</completion_date>
  <primary_completion_date type="Anticipated">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>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Tumor response</measure>
    <time_frame>3 Months</time_frame>
    <description>Tumor response evaluated by postoperative CT/MRI scan according to RECIST criteria.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>30 days</time_frame>
    <description>Number of adverse events. Postoperative adverse events were graded based on CTCAE v4.03</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of of Patients developed Adverse Events</measure>
    <time_frame>30 days</time_frame>
    <description>Number of of patients who developed adverse event. Postoperative adverse events were graded based on CTCAE v4.03</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">54</enrollment>
  <condition>HepatoCellular Carcinoma</condition>
  <arm_group>
    <arm_group_label>Full Dosage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Full Dosage Chemotherapy regimen administered by HAI</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low Dosage of 5-Fu</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Low Dose of 5-Fu Chemotherapy regimen administered by HAI</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low Dosage of oxaliplatin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Low Dose of oxaliplatin Chemotherapy regimen administered by HAI</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>5-Fu, oxaliplatin , leucovorin</intervention_name>
    <description>Drug: 5-Fu, oxaliplatin and regular dose of leucovorin Regimen: (1) 5-Fu: 2800 mg/m2 (2) oxaliplatin: 135 mg/m2 (3) leucovorin: 400mg/m2</description>
    <arm_group_label>Full Dosage</arm_group_label>
    <other_name>Full dose Folfox</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>5-Fu, oxaliplatin , leucovorin</intervention_name>
    <description>Drug: 5-Fu, oxaliplatin and regular dosage of leucovorin Regimen: (1) 5-Fu: 1400 mg/m2 (2) oxaliplatin: 135 mg/m2 (3) leucovorin: 400mg/m2</description>
    <arm_group_label>Low Dosage of 5-Fu</arm_group_label>
    <other_name>Low dose 5-Fu Folfox</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>5-Fu, oxaliplatin , leucovorin</intervention_name>
    <description>Drug: 5-Fu, oxaliplatin and regular dosage of leucovorin Regimen: (1) 5-Fu: 2800 mg/m2 (2) oxaliplatin: 85 mg/m2 (3) leucovorin: 400mg/m2</description>
    <arm_group_label>Low Dosage of oxaliplatin</arm_group_label>
    <other_name>Low dose oxaliplatin Folfox</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        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) Patients must have at least one tumor lesion&#xD;
        that can be accurately measured according to EASL criteria.&#xD;
&#xD;
        diagnosed with major or main portal vein invasion (Vp3 or Vp4) KPS≥70； with no previous&#xD;
        treatment No Cirrhosis or cirrhotic status of Child-Pugh class A only Not amendable to&#xD;
        surgical resection ,local ablative therapy and any other cured treatment.&#xD;
&#xD;
        The following laboratory parameters:&#xD;
&#xD;
        Platelet count ≥ 75,000/µL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥&#xD;
        30 g/L ASL and AST ≤ 5 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;
        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 hepatic&#xD;
        encephalopathy Known history of HIV History of organ allograft Known or suspected allergy&#xD;
        to the investigational agents or any agent given in association with this trial.&#xD;
&#xD;
        Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy Evidence of bleeding&#xD;
        diathesis. Patients with clinically significant gastrointestinal bleeding within 30 days&#xD;
        prior to study entry.&#xD;
&#xD;
        Any other hemorrhage/bleeding event &gt; CTCAE Grade 3 within 4 weeks of first dose of study&#xD;
        drug Serious non-healing wound, ulcer, or bone fracture Known central nervous system tumors&#xD;
        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, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Department of Hepatobiliary Pancreatic Oncology of Sun Yat-sen University Cancer Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ming Shi, Doctor</last_name>
    <phone>(8620)-87343938</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>
      <email>shiming@sysu.edu.cn</email>
    </contact>
    <investigator>
      <last_name>shi Ming, MD.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </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>Llovet JM, Bruix J. Systematic review of randomized trials for unresectable hepatocellular carcinoma: Chemoembolization improves survival. Hepatology. 2003 Feb;37(2):429-42. doi: 10.1053/jhep.2003.50047.</citation>
    <PMID>12540794</PMID>
  </results_reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>December 27, 2016</last_update_submitted>
  <last_update_submitted_qc>December 27, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 28, 2016</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>Professor</investigator_title>
  </responsible_party>
  <keyword>Hepatocellular Carcinoma</keyword>
  <keyword>Hepatic arterial infusion chemotherapy</keyword>
  <keyword>optimal dose</keyword>
  <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>Leucovorin</mesh_term>
    <mesh_term>Oxaliplatin</mesh_term>
    <mesh_term>Fluorouracil</mesh_term>
    <mesh_term>Levoleucovorin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02987699
org study id: Unique Protocol ID: HCC-S026
nct id: NCT02987699
lead sponsor: 
has dmc: Yes
The purpose of this phase II study is to determine the recommended dose, as well as the
      safety and efficacy of the combination of oxaliplatin, leucovorin and 5-Fu introduced by
      hepatic arterial infusion chemotherapy (HAIC) in patients with advanced hepatocellular
      carcinoma (HCC).
The results of our preliminary pilot study suggested that the combination of oxaliplatin,
      leucovorin and 5-Fu introduced by hepatic arterial infusion chemotherapy (HAIC) may improve
      the survivals for advanced stage HCC. Thus, the investigators carried out this prospective
      randomized control study to determine the recommended dose as well as the safety and
      efficacy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Tumor response
time frame: 3 Months
description: Tumor response evaluated by postoperative CT/MRI scan according to RECIST criteria.
measure: Adverse Events
time frame: 30 days
description: Number of adverse events. Postoperative adverse events were graded based on CTCAE v4.03
measure: Number of of Patients developed Adverse Events
time frame: 30 days
description: Number of of patients who developed adverse event. Postoperative adverse events were graded based on CTCAE v4.03
arm group label: Full Dosage
arm group type: Experimental
description: Full Dosage Chemotherapy regimen administered by HAI
arm group label: Low Dosage of 5-Fu
arm group type: Experimental
description: Low Dose of 5-Fu Chemotherapy regimen administered by HAI
arm group label: Low Dosage of oxaliplatin
arm group type: Experimental
description: Low Dose of oxaliplatin Chemotherapy regimen administered by HAI
intervention type: Drug
intervention name: 5-Fu, oxaliplatin , leucovorin
description: Drug: 5-Fu, oxaliplatin and regular dose of leucovorin Regimen: (1) 5-Fu: 2800 mg/m2 (2) oxaliplatin: 135 mg/m2 (3) leucovorin: 400mg/m2
arm group label: Full Dosage
other name: Full dose Folfox
intervention type: Drug
intervention name: 5-Fu, oxaliplatin , leucovorin
description: Drug: 5-Fu, oxaliplatin and regular dosage of leucovorin Regimen: (1) 5-Fu: 1400 mg/m2 (2) oxaliplatin: 135 mg/m2 (3) leucovorin: 400mg/m2
arm group label: Low Dosage of 5-Fu
other name: Low dose 5-Fu Folfox
intervention type: Drug
intervention name: 5-Fu, oxaliplatin , leucovorin
description: Drug: 5-Fu, oxaliplatin and regular dosage of leucovorin Regimen: (1) 5-Fu: 2800 mg/m2 (2) oxaliplatin: 85 mg/m2 (3) leucovorin: 400mg/m2
arm group label: Low Dosage of oxaliplatin
other name: Low dose oxaliplatin Folfox
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Ming Shi, Doctor
role: Principal Investigator
affiliation: The Department of Hepatobiliary Pancreatic Oncology of Sun Yat-sen University Cancer Center
last name: Ming Shi, Doctor
phone: (8620)-87343938
email: shiming@sysucc.org.cn
facility: 
status: Recruiting
contact: 
investigator: 
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: Llovet JM, Bruix J. Systematic review of randomized trials for unresectable hepatocellular carcinoma: Chemoembolization improves survival. Hepatology. 2003 Feb;37(2):429-42. doi: 10.1053/jhep.2003.50047.
PMID: 12540794
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Shi Ming
investigator title: Professor
mesh term: Carcinoma, Hepatocellular
mesh term: Leucovorin
mesh term: Oxaliplatin
mesh term: Fluorouracil
mesh term: Levoleucovorin
sharing ipd: Undecided