<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/NCT02259647</url>
  </required_header>
  <id_info>
    <org_study_id>ILBS-HCC-02</org_study_id>
    <nct_id>NCT02259647</nct_id>
  </id_info>
  <brief_title>Sorafenib Plus Vitamin K1 Versus Sorafenib in Advanced Hepatocellular Carcinoma</brief_title>
  <official_title>Sorafenib Plus Vitamin K1 Versus Sorafenib in Advanced Hepatocellular Carcinoma - a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institute of Liver and Biliary Sciences, India</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institute of Liver and Biliary Sciences, India</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      60 patients of radiological, biopsy proven advanced HCC (Hepatocellular carcinoma) patient&#xD;
      will be randomized into two groups. Cases group will receive Sorafenib plus vitamin K and&#xD;
      control group will receive Sorafenib plus placebo&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2014</start_date>
  <completion_date type="Actual">October 31, 2015</completion_date>
  <primary_completion_date type="Actual">October 31, 2015</primary_completion_date>
  <phase>N/A</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>1 Year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective response rate (ORR) of tumour based on mRECIST (Response Evaluation Criteria In Solid Tumors ) criteria</measure>
    <time_frame>3 months</time_frame>
    <description>ORR (Objective response rate) as the percentage of randomly assigned patients with complete response or partial response based on mRECIST (Response Evaluation Criteria In Solid Tumors ) criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease control rate (DCR) of tumour based on mRECIST (Response Evaluation Criteria In Solid Tumors ) criteria</measure>
    <time_frame>3 months</time_frame>
    <description>DCR (Disease control rate) as the percentage of randomly assigned patients with complete response, partial response, or stable disease based on mRECIST (Response Evaluation Criteria In Solid Tumors ) criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biochemical response - improvement in tumor biomarker level</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety</measure>
    <time_frame>1 Years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Hepatocellular Carcinoma</condition>
  <arm_group>
    <arm_group_label>Sorafenib +intravenous infusion ofVit K1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sorafenib 400mg twice daily + intravenous infusion ofVit K1 50 mg/day with daily increase of dose by 50 mg for 6 days, followed by oral Vitamin K1 20mg twice daily for 3month</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sorafenib+Placebo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sorafenib 400 mg twice daily + Intravenousinfusion of placebo daily for 6 days, followed by oral placebo twice daily till 3month</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sorafenib 400mg twice daily + intravenous infusion ofVit K1</intervention_name>
    <description>Sorafenib 400mg twice daily + intravenous infusion ofVit K1 50 mg/day with daily increase of dose by 50 mg for 6 days, followed by oral Vitamin K1 20mg twice daily for 3month</description>
    <arm_group_label>Sorafenib +intravenous infusion ofVit K1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sorafenib 400 mg twice daily + Intravenousinfusion of placebo</intervention_name>
    <description>Sorafenib 400 mg twice daily + Intravenousinfusion ofplacebo daily for 6 days, followed by oral placebo twice daily x 3month</description>
    <arm_group_label>Sorafenib+Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 to 70 years&#xD;
&#xD;
          -  Child A and B cirrhosis with hepatocellular carcinoma&#xD;
&#xD;
          -  Biochemical, Radiological, histological evidence of advanced hepatocellular carcinoma&#xD;
             diagnosed as stage C and stage d with serum bilirubin &lt;5 mg/dl according to BCLC&#xD;
             staging system&#xD;
&#xD;
          -  HCC with portal vein thrombosis&#xD;
&#xD;
          -  Unresectable cancer, as assessed carefully by individual experts&#xD;
&#xD;
          -  No recent active treatment like surgery, radiofrequency ablation, trans arterial chemo&#xD;
             embolization, radiotherapy, chemotherapy (within the past 6 months)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with end-stage hepatocellular carcinoma (Stage D, BCLC)with poor performance&#xD;
             status&#xD;
&#xD;
          -  Child C cirrhosis with HCC (Hepatocellular carcinoma)&#xD;
&#xD;
          -  HCC with acute decompensated state of CLD - GI bleed, increased jaundice, HE, SBP&#xD;
             (Spontaneous Bacterial Peritonitis)&#xD;
&#xD;
          -  Acute febrile illness&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Institute of Liver &amp; Biliary Sciences</name>
      <address>
        <city>New Delhi</city>
        <state>Delhi</state>
        <zip>110070</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>September 11, 2014</study_first_submitted>
  <study_first_submitted_qc>October 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2014</study_first_posted>
  <last_update_submitted>October 25, 2019</last_update_submitted>
  <last_update_submitted_qc>October 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>
  <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/NCT02259647
org study id: ILBS-HCC-02
nct id: NCT02259647
lead sponsor: 
has dmc: No
60 patients of radiological, biopsy proven advanced HCC (Hepatocellular carcinoma) patient
      will be randomized into two groups. Cases group will receive Sorafenib plus vitamin K and
      control group will receive Sorafenib plus placebo
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Overall Survival
time frame: 1 Year
measure: Objective response rate (ORR) of tumour based on mRECIST (Response Evaluation Criteria In Solid Tumors ) criteria
time frame: 3 months
description: ORR (Objective response rate) as the percentage of randomly assigned patients with complete response or partial response based on mRECIST (Response Evaluation Criteria In Solid Tumors ) criteria
measure: Disease control rate (DCR) of tumour based on mRECIST (Response Evaluation Criteria In Solid Tumors ) criteria
time frame: 3 months
description: DCR (Disease control rate) as the percentage of randomly assigned patients with complete response, partial response, or stable disease based on mRECIST (Response Evaluation Criteria In Solid Tumors ) criteria.
measure: Biochemical response - improvement in tumor biomarker level
time frame: 3 months
measure: Safety
time frame: 1 Years
arm group label: Sorafenib +intravenous infusion ofVit K1
arm group type: Experimental
description: Sorafenib 400mg twice daily + intravenous infusion ofVit K1 50 mg/day with daily increase of dose by 50 mg for 6 days, followed by oral Vitamin K1 20mg twice daily for 3month
arm group label: Sorafenib+Placebo
arm group type: Active Comparator
description: Sorafenib 400 mg twice daily + Intravenousinfusion of placebo daily for 6 days, followed by oral placebo twice daily till 3month
intervention type: Drug
intervention name: Sorafenib 400mg twice daily + intravenous infusion ofVit K1
description: Sorafenib 400mg twice daily + intravenous infusion ofVit K1 50 mg/day with daily increase of dose by 50 mg for 6 days, followed by oral Vitamin K1 20mg twice daily for 3month
arm group label: Sorafenib +intravenous infusion ofVit K1
intervention type: Drug
intervention name: Sorafenib 400 mg twice daily + Intravenousinfusion of placebo
description: Sorafenib 400 mg twice daily + Intravenousinfusion ofplacebo daily for 6 days, followed by oral placebo twice daily x 3month
arm group label: Sorafenib+Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: India
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular
mesh term: Sorafenib