<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/NCT02971696</url>
  </required_header>
  <id_info>
    <org_study_id>40</org_study_id>
    <nct_id>NCT02971696</nct_id>
  </id_info>
  <brief_title>Sorafenib Versus Best Supportive Care in Egyptian Hepatocellular Carcinoma Patients.</brief_title>
  <official_title>Sorafenib Versus Best Supportive Care in Egyptian Hepatocellular Carcinoma Patients. Prospective Phase III Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to evaluate the efficacy of sorafenib, compared to the best&#xD;
      supportive care (BSC), in two cohorts of patients who presented with advanced hepatocellular&#xD;
      carcinoma (HCC) based on etiology of hepatitis C virus.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In Egypt, chronic hepatitis C virus (HCV) infection occurs in around 10% of the population&#xD;
      (about 8 million individuals), and is a leading cause of liver cirrhosis, hepatocellular&#xD;
      carcinoma, and mortality. Although HCV genotype 4 constitutes about 20% of HCV infections&#xD;
      worldwide, the prevalence in Egypt is more than 90%.(Waked et al., 2016)&#xD;
&#xD;
      In 2014 Omar et al. reviewed 41 patients in a study to evaluate Sorafenib for Egyptian&#xD;
      patients with advanced hepatocellular carcinoma at a median follow up period of 13 months,&#xD;
      the median PFS for the whole group was 4 months; the median OS for the whole group is 6.25&#xD;
      months.(Abdel-Rahman et al., 2014)&#xD;
&#xD;
      Till current, no studies have evaluated the Sorafenib efficacy in comparison to the best&#xD;
      supportive care treatment in HCC patients whose etiology from HCV genotype 4 ( the most&#xD;
      prevalent hepatitis C virus genotype in Egypt).&#xD;
&#xD;
      So, The study aims to evaluate the efficacy of sorafenib, compared to the best supportive&#xD;
      care (BSC), in two cohorts of patients who presented with advanced hepatocellular carcinoma&#xD;
      (HCC) based on etiology of hepatitis C virus.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">January 2018</completion_date>
  <primary_completion_date type="Actual">November 2017</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-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 (OS)</measure>
    <time_frame>12 months</time_frame>
    <description>Overall survival is defined as the duration from the start of treatment date till date of last contact or death date.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Event free survival</measure>
    <time_frame>12 months</time_frame>
    <description>Event free survival was defined as the duration from the date of diagnosis till the date of first event (death, radiological progression, symptomatic progression) or the date of last contact if the patient did not develop the event.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Detection of changes in quality of life</measure>
    <time_frame>12 months</time_frame>
    <description>through application of QLQ FHSI-8 questionnaire every two months in both arms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sorafenib induced side effects</measure>
    <time_frame>12 months</time_frame>
    <description>incidence and severity</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>HCC</condition>
  <arm_group>
    <arm_group_label>HCC patients (Group 1)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sorafenib will be administrated at a dose of 400 mg twice daily (consisting of two 200-mg tablets).Treatment interruptions and up to two dose reductions (first to 400 mg once daily and then to 400 mg every 2 days) will permitted for drug- related adverse effects. If further dose reductions will required, patients will withdraw from the study</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HCC patients (Group 2)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patient will take best supportive care</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sorafenib</intervention_name>
    <description>Sorafenib will be administrated at a dose of 400 mg twice daily (consisting of two 200-mg tablets).Treatment interruptions and up to two dose reductions (first to 400 mg once daily and then to 400 mg every 2 days) will permitted for drug- related adverse effects. If further dose reductions will required, patients will withdraw from the study</description>
    <arm_group_label>HCC patients (Group 1)</arm_group_label>
    <other_name>nexavar</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Best Supportive care</intervention_name>
    <description>Liver Support, pain management</description>
    <arm_group_label>HCC patients (Group 2)</arm_group_label>
    <other_name>Liver Support</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients ≥18 years of age&#xD;
&#xD;
          2. Patients based on etiology of hepatitis C virus.&#xD;
&#xD;
          3. Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less&#xD;
&#xD;
          4. Child-Pugh liver function class A,B&#xD;
&#xD;
          5. A life expectancy of 12 weeks or more&#xD;
&#xD;
          6. adequate hematologic function (platelet count, ≥60×109 per liter; hemoglobin, ≥8.5 g&#xD;
             per deciliter; and prothrombin time international normalized ratio, ≤2.3; or&#xD;
             prothrombin time, ≤6 seconds above control), adequate hepatic function (albumin, ≥2.8&#xD;
             g per deciliter; total bilirubin, ≤3 mg per deciliter [51.3 µmol per liter]; and&#xD;
             alanine aminotransferase and aspartate aminotransferase, ≤5 times the upper limit of&#xD;
             the normal range), and adequate renal function (serum creatinine, ≤1.5 times the upper&#xD;
             limit of the normal range).&#xD;
&#xD;
          7. Patients were required to have at least one untreated target lesion that could be&#xD;
             measured in one dimension, according to the Response Evaluation Criteria in Solid&#xD;
             Tumors (RECIST)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Had previously received molecularly targeted therapies or any other systemic&#xD;
             treatment.&#xD;
&#xD;
          2. Any co morbid disease that will confuse the assessment of the Quality of life&#xD;
             questionnaire scoreFHSI-8 score.&#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>AbdelRahman Elnaggar, Prof.</last_name>
    <role>Study Chair</role>
    <affiliation>MTI University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>El Kahraba Hosital</name>
      <address>
        <city>Cairo</city>
        <state>N/A = Not Applicable</state>
        <zip>1234</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ain Shams University Hospital</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nasser Institute</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>June 26, 2018</last_update_submitted>
  <last_update_submitted_qc>June 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Noha El Baghdady</investigator_full_name>
    <investigator_title>Ph.D Candidate</investigator_title>
  </responsible_party>
  <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>Sorafenib</mesh_term>
  </intervention_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/NCT02971696
org study id: 40
nct id: NCT02971696
lead sponsor: 
has dmc: Yes
The aim of the study is to evaluate the efficacy of sorafenib, compared to the best
      supportive care (BSC), in two cohorts of patients who presented with advanced hepatocellular
      carcinoma (HCC) based on etiology of hepatitis C virus.
In Egypt, chronic hepatitis C virus (HCV) infection occurs in around 10% of the population
      (about 8 million individuals), and is a leading cause of liver cirrhosis, hepatocellular
      carcinoma, and mortality. Although HCV genotype 4 constitutes about 20% of HCV infections
      worldwide, the prevalence in Egypt is more than 90%.(Waked et al., 2016)

      In 2014 Omar et al. reviewed 41 patients in a study to evaluate Sorafenib for Egyptian
      patients with advanced hepatocellular carcinoma at a median follow up period of 13 months,
      the median PFS for the whole group was 4 months; the median OS for the whole group is 6.25
      months.(Abdel-Rahman et al., 2014)

      Till current, no studies have evaluated the Sorafenib efficacy in comparison to the best
      supportive care treatment in HCC patients whose etiology from HCV genotype 4 ( the most
      prevalent hepatitis C virus genotype in Egypt).

      So, The study aims to evaluate the efficacy of sorafenib, compared to the best supportive
      care (BSC), in two cohorts of patients who presented with advanced hepatocellular carcinoma
      (HCC) based on etiology of hepatitis C virus.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: overall survival (OS)
time frame: 12 months
description: Overall survival is defined as the duration from the start of treatment date till date of last contact or death date.
measure: Event free survival
time frame: 12 months
description: Event free survival was defined as the duration from the date of diagnosis till the date of first event (death, radiological progression, symptomatic progression) or the date of last contact if the patient did not develop the event.
measure: Detection of changes in quality of life
time frame: 12 months
description: through application of QLQ FHSI-8 questionnaire every two months in both arms
measure: Sorafenib induced side effects
time frame: 12 months
description: incidence and severity
arm group label: HCC patients (Group 1)
arm group type: Experimental
description: Sorafenib will be administrated at a dose of 400 mg twice daily (consisting of two 200-mg tablets).Treatment interruptions and up to two dose reductions (first to 400 mg once daily and then to 400 mg every 2 days) will permitted for drug- related adverse effects. If further dose reductions will required, patients will withdraw from the study
arm group label: HCC patients (Group 2)
arm group type: Active Comparator
description: Patient will take best supportive care
intervention type: Drug
intervention name: Sorafenib
description: Sorafenib will be administrated at a dose of 400 mg twice daily (consisting of two 200-mg tablets).Treatment interruptions and up to two dose reductions (first to 400 mg once daily and then to 400 mg every 2 days) will permitted for drug- related adverse effects. If further dose reductions will required, patients will withdraw from the study
arm group label: HCC patients (Group 1)
other name: nexavar
intervention type: Drug
intervention name: Best Supportive care
description: Liver Support, pain management
arm group label: HCC patients (Group 2)
other name: Liver Support
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: AbdelRahman Elnaggar, Prof.
role: Study Chair
affiliation: MTI University
facility: 
facility: 
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Noha El Baghdady
investigator title: Ph.D Candidate
mesh term: Carcinoma, Hepatocellular
mesh term: Sorafenib
sharing ipd: No