<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/NCT03766776</url>
  </required_header>
  <id_info>
    <org_study_id>2018-SR-273</org_study_id>
    <nct_id>NCT03766776</nct_id>
  </id_info>
  <brief_title>Anlotinib in the Treatment of Advanced Hepatocellular Carcinoma (HCC)</brief_title>
  <acronym>ATAHC</acronym>
  <official_title>Anlotinib Hydrochloride Capsules in the Treatment of Advanced Hepatocellular Carcinoma (HCC) Open, Single Arm, Exploratory Clinical Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First Affiliated Hospital with Nanjing Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The First Affiliated Hospital with Nanjing Medical 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>
      This is a prospective, one-arm, exploratory clinical study to observe and evaluate the&#xD;
      efficacy and safety of Anlotinib hydrochloride capsules in patients with advanced liver&#xD;
      cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 31, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2019</primary_completion_date>
  <phase>N/A</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>PFS</measure>
    <time_frame>3 month</time_frame>
    <description>Progression free survival</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Cancer of Liver</condition>
  <arm_group>
    <arm_group_label>Anlotinib Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Anlotinib</intervention_name>
    <description>Anlotinib capsules: dosage of 12 mg PO qd, 14 days, 7 days, 21 days for a cycle. The dosage was adjusted according to the adverse reactions of patients.</description>
    <arm_group_label>Anlotinib Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 18 to 75 years old.&#xD;
&#xD;
          -  At least one measurable lesion (the length of spiral CT scan (&gt; 10mm) meets the&#xD;
             requirements of RESCIST 1.1) is found in patients with HCC confirmed by histopathology&#xD;
             or cytology or who meet the clinical diagnostic criteria.&#xD;
&#xD;
          -  Inability or unwillingness to undergo surgery and transcatheter hepatic artery&#xD;
             interventional therapy; if interventional therapy, radiotherapy or surgery has been&#xD;
             accepted, it must be more than 4 weeks, and adverse reactions or wounds have fully&#xD;
             recovered.&#xD;
&#xD;
          -  No treatment with sorafenib or other systemic treatment was received. Patients who&#xD;
             have used interventional chemotherapeutic drugs during interventional therapy may be&#xD;
             enrolled in the group.&#xD;
&#xD;
          -  Child-Pugh liver function rating: grade A or B; BCLC stage B or C.&#xD;
&#xD;
          -  ECOG PS：0-2.&#xD;
&#xD;
          -  The life expectancy is more than 12 weeks.&#xD;
&#xD;
          -  The main organs are functioning normally, which meets the following criteria:&#xD;
&#xD;
             (1) Blood routine examination: A. HB &gt; 90 g/L; (No blood transfusion within 14 days)&#xD;
             B. ANC is more than 1.5 x /L; C. PLT is more than 50 x /L; (2) Biochemical&#xD;
             examination: A. ALT and AST &lt; 5_ULN; B. TBIL &lt; 1.5_ULN; C. Plasma Cr &lt; 1.5_ULN.&#xD;
&#xD;
          -  Subjects volunteered to join the study, signed informed consent, good compliance, with&#xD;
             follow-up.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hepatobiliary and mixed cell carcinomas and fiberboard cell carcinomas are known;&#xD;
             other malignant tumors (except cured cutaneous basal cell carcinomas and cervical&#xD;
             carcinoma in situ) have been reported in the past or at the same time.&#xD;
&#xD;
          -  Pregnant or lactating women .&#xD;
&#xD;
          -  Patients with hypertension who could not be well controlled by antihypertensive drugs&#xD;
             (systolic blood pressure &gt; 150 mmHg, diastolic blood pressure &gt; 100 mmHg), patients&#xD;
             with myocardial ischemia or myocardial infarction above grade II, arrhythmias with&#xD;
             poor control (including QTC interval &gt; 450 ms) and cardiac insufficiency of grade&#xD;
             III-IV according to NYHA standard.&#xD;
&#xD;
          -  Inability to swallow, chronic diarrhea and intestinal obstruction significantly affect&#xD;
             drug use and absorption.&#xD;
&#xD;
          -  There are clear concerns about gastrointestinal bleeding (such as local active ulcer&#xD;
             lesions, fecal occult blood +) or more), and there is a history of gastrointestinal&#xD;
             bleeding within 6 months.&#xD;
&#xD;
          -  Central nervous system metastasis has occurred.&#xD;
&#xD;
          -  Coagulation dysfunction (PT &gt; 16 s, APTT &gt; 43 s, TT &gt; 21 s, Fbg &lt; 2 g/L), with&#xD;
             bleeding tendency or undergoing thrombolysis or anticoagulation therapy.&#xD;
&#xD;
          -  Have a history of mental illness or psychotropic drug abuse.&#xD;
&#xD;
          -  Peritoneal effusion with clinical symptoms requires therapeutic abdominal puncture or&#xD;
             drainage, or Child-Pugh score (&gt; 2).&#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>Yongqian Shu, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>JANGSU PROVINCE HOSPITAL</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yongqian Shu, PhD</last_name>
    <phone>0086-13813804568</phone>
    <email>shuyongqian@csco.org.cn</email>
  </overall_contact>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>December 9, 2018</last_update_submitted>
  <last_update_submitted_qc>December 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 11, 2018</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, Hepatocellular</mesh_term>
    <mesh_term>Liver Neoplasms</mesh_term>
  </condition_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/NCT03766776
org study id: 2018-SR-273
nct id: NCT03766776
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This is a prospective, one-arm, exploratory clinical study to observe and evaluate the
      efficacy and safety of Anlotinib hydrochloride capsules in patients with advanced liver
      cancer.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: PFS
time frame: 3 month
description: Progression free survival
arm group label: Anlotinib Arm
arm group type: Experimental
intervention type: Drug
intervention name: Anlotinib
description: Anlotinib capsules: dosage of 12 mg PO qd, 14 days, 7 days, 21 days for a cycle. The dosage was adjusted according to the adverse reactions of patients.
arm group label: Anlotinib Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Yongqian Shu, PhD
role: Study Chair
affiliation: JANGSU PROVINCE HOSPITAL
last name: Yongqian Shu, PhD
phone: 0086-13813804568
email: shuyongqian@csco.org.cn
responsible party type: Sponsor
mesh term: Carcinoma, Hepatocellular
mesh term: Liver Neoplasms
sharing ipd: Undecided