xml: <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/NCT05994365</url>
    </required_header>
    <id_info>
      <org_study_id>A LOT-DTC-1</org_study_id>
      <nct_id>NCT05994365</nct_id>
    </id_info>
    <brief_title>Study of Anlotinib Hydrochloride Capsules in the Treatment of Locally Advanced or Metastatic Radioiodine-Refractory Differentiated Thyroid Carcinoma</brief_title>
    <official_title>A Real-world Study of Anlotinib Hydrochloride Capsules in the Treatment of Locally Advanced or Metastatic Radioiodine-Refractory Differentiated Thyroid Carcinoma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Chia Tai Tianqing Pharmaceutical Group Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Chia Tai Tianqing Pharmaceutical Group Co., Ltd.</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>
        The study aims to observe and investigate the efficacy and safety of Anlotinib capsules in&#xD;
        patients with locally advanced or metastatic radioiodine-refractory differentiated thyroid&#xD;
        carcinoma in the real world, and to summarize the treatment experience in a broad population.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">December 2028</completion_date>
    <primary_completion_date type="Anticipated">August 2027</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Overall Response Rate (ORR)</measure>
      <time_frame>Baseline up to 3 years.</time_frame>
      <description>The proportion of subjects who achieves a best overall response of complete response (CR) or partial response (PR).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Progression-free Survival (PFS)</measure>
      <time_frame>Baseline up to 3 years.</time_frame>
      <description>From the first dose to the date of objective disease progression or death, whichever occurs first.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Disease-control Rate (DCR)</measure>
      <time_frame>Baseline up to 3 years.</time_frame>
      <description>The proportion of subjects response of CR, PR, or stable disease (SD), subjects achieving SD will be included in the DCR if they maintain SD for ≥4 weeks.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of Response (DOR)</measure>
      <time_frame>Baseline up to 3 years.</time_frame>
      <description>From the date that CR or PR are first occurred to the date of objective disease progression or death, whichever occurs first.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall Survival (OS)</measure>
      <time_frame>Baseline up to 3 years.</time_frame>
      <description>From randomization to the time of death from any cause.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse event rate</measure>
      <time_frame>Baseline up to 3 years.</time_frame>
      <description>The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">380</enrollment>
    <condition>Thyroid Neoplasms</condition>
    <arm_group>
      <arm_group_label>Anlotinib group</arm_group_label>
      <description>Anlotinib hydrochloride capsules: 12 mg once daily for 2 weeks, followed by a discontinuation of 1 week (21 days as a cycle)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Observation group</arm_group_label>
      <description>Observation: prospectively and retrospectively collect data of patients who did not receive anlotinib hydrochloride capsules or similar small-molecule antivascular inhibitors.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Anlotinib Hydrochloride Capsule</intervention_name>
      <description>Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor that inhibits both tumor angiogenesis and tumor cell proliferation.</description>
      <arm_group_label>Anlotinib group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Locally Advanced or Metastatic Radioiodine-Refractory Differentiated Thyroid Carcinoma&#xD;
          Patients&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients voluntarily participate in this study, sign the informed consent form and had&#xD;
               good compliance;&#xD;
  &#xD;
            -  Aged 18 ~ 70 years old; Eastern Cooperative Oncology Group Performance Status (ECOG&#xD;
               PS) score: 0~1; more than 6 months of expected survival ;&#xD;
  &#xD;
            -  Histopathologically confirmed locally advanced or metastatic differentiated thyroid&#xD;
               cancer, radiographically documented disease progression within 18 months of absence of&#xD;
               radioactive iodine (RAI) therapy;&#xD;
  &#xD;
            -  Meet any of the following:&#xD;
  &#xD;
                 1. Lesions were not iodine-avid: no RAI uptake was confirmed after RAI scan in the&#xD;
                    presence of a low-iodine diet, adequate thyroid stimulating hormone (TSH)&#xD;
                    elevation (≥ 30 mIU/L). The definition of no iodine uptake:&#xD;
  &#xD;
                      1. no iodine uptake initially;&#xD;
  &#xD;
                      2. exist of iodine uptake initially while lost subsequently;&#xD;
  &#xD;
                      3. partially uptake;&#xD;
  &#xD;
                      4. progression disease despite iodine uptake.&#xD;
  &#xD;
                 2. The cumulative dose of RAI was ≥ 600 mCi or 22 GBq, with an interval of at least&#xD;
                    3 months.&#xD;
  &#xD;
                 3. Radiographically documented disease progression within 18 months of RAI therapy&#xD;
                    despite the presence of iodine-131 affinity at the time of RAI therapy;&#xD;
  &#xD;
            -  At least one measurable lesion according to Response Evaluation Criteria in Solid&#xD;
               Tumours (RECIST) 1.1.&#xD;
  &#xD;
            -  Major organ functions meet the following criteria within 7 days prior to treatment:&#xD;
  &#xD;
                 1. Blood routine test criteria (14 days without blood transfusion):&#xD;
  &#xD;
                      1. Hemoglobin (HB) ≥ 85 g/L;&#xD;
  &#xD;
                      2. Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L;&#xD;
  &#xD;
                      3. Platelet (PLT) ≥ 80 × 10^9/L&#xD;
  &#xD;
                 2. Biochemical tests need to meet the following criteria:&#xD;
  &#xD;
                      1. Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN);&#xD;
  &#xD;
                      2. Alanine aminotransferase (ALT) and aspartate aminotransferase AST ≤ 2&#xD;
                         .5×ULN, ALT and AS if liver metastases T ≤ 5 ×ULN;&#xD;
  &#xD;
                      3. Serum creatinine (Cr) ≤ 1 .5 ×ULN or creatinine clearance (CCr) ≥ 60 Ml/min;&#xD;
  &#xD;
            -  Females of childbearing potential should agree to use contraceptive measures (such as&#xD;
               intrauterine device, contraceptives or condoms) during the study and within 6 months&#xD;
               after the end of the study; have a negative serum or urine pregnancy test within 7&#xD;
               days before study enrollment and must be non-lactating patients; and males should&#xD;
               agree to use contraceptive measures during the study and within 6 months after the end&#xD;
               of the study period.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Comorbidities and medical history:&#xD;
  &#xD;
                 1. A history of or concurrent with other malignancies within the past 3 years.&#xD;
                    Patients were eligible if they had disease-free survival (DFS) for 5 consecutive&#xD;
                    years in other malignancies treated by single surgery; Cured cervical carcinoma&#xD;
                    in situ, non-melanoma skin cancer and superficial bladder tumors [Ta&#xD;
                    (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement&#xD;
                    membrane)];&#xD;
  &#xD;
                 2. Major surgical treatment, open biopsy, or significant traumatic injury within 28&#xD;
                    days before the start of study treatment;&#xD;
  &#xD;
                 3. Subjects with any severe and/or uncontrolled illness, including:&#xD;
  &#xD;
                      1. Patients with ≥ grade 2 myocardial ischemia or myocardial infarction,&#xD;
                         arrhythmia (including Corrected QT Interval (QTc)≥450ms(male), QTc≥&#xD;
                         470ms(female)) and ≥ grade 2 congestive heart failure (NYHA classification);&#xD;
  &#xD;
                      2. Severe active or uncontrolled infection (≥ grade 2 infection according to&#xD;
                         Common Terminology Criteria for Adverse Events (CTCAE) );&#xD;
  &#xD;
                      3. Renal failure requiring hemodialysis or peritoneal dialysis;&#xD;
  &#xD;
            -  Patients with concomitant diseases that seriously endanger the safety of patients or&#xD;
               affect the completion of the study, or patients who are considered to be unsuitable&#xD;
               for enrollment for other reasons according to the judgment of the investigators.&#xD;
  &#xD;
            -  patients with previous treatment with anlotinib hydrochloride capsules or similar&#xD;
               vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI)&#xD;
               small molecule drugs, such as vandetanib, Cabozantinib, lenvatinib, sunitinib, or&#xD;
               sorafenib, etc.;&#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_contact>
      <last_name>Ming Gao, PhD</last_name>
      <phone>+ 86 18622221110</phone>
      <email>gaoming68@aliyun.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Yansong Lin, PhD</last_name>
      <phone>+86 13671116837</phone>
      <email>linys@pumch.cn</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Peking Union Medical College Hospital, Chinese Academy of Medical Sciences</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100007</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yansong Lin, PhD</last_name>
        <phone>+86 13671116837</phone>
        <email>linys@pumch.cn</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Tianjin People's Hospital</name>
        <address>
          <city>Tianjin</city>
          <state>Tianjin</state>
          <zip>300122</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ming Gao, PhD</last_name>
        <phone>+ 86 18622221110</phone>
        <email>gaoming68@aliyun.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Tianjin Cancer Hospital</name>
        <address>
          <city>Tianjin</city>
          <state>Tianjin</state>
          <zip>300181</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Xiangqian Zheng, PhD</last_name>
        <phone>+86 18622220506</phone>
        <email>xiangqian_zheng@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</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>Thyroid Neoplasms</mesh_term>
      <mesh_term>Thyroid Diseases</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05994365
  org study id: A LOT-DTC-1
  nct id: NCT05994365
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The study aims to observe and investigate the efficacy and safety of Anlotinib capsules in
        patients with locally advanced or metastatic radioiodine-refractory differentiated thyroid
        carcinoma in the real world, and to summarize the treatment experience in a broad population.
  observational model: Cohort
  time perspective: Prospective
  measure: Overall Response Rate (ORR)
  time frame: Baseline up to 3 years.
  description: The proportion of subjects who achieves a best overall response of complete response (CR) or partial response (PR).
  measure: Progression-free Survival (PFS)
  time frame: Baseline up to 3 years.
  description: From the first dose to the date of objective disease progression or death, whichever occurs first.
  measure: Disease-control Rate (DCR)
  time frame: Baseline up to 3 years.
  description: The proportion of subjects response of CR, PR, or stable disease (SD), subjects achieving SD will be included in the DCR if they maintain SD for ≥4 weeks.
  measure: Duration of Response (DOR)
  time frame: Baseline up to 3 years.
  description: From the date that CR or PR are first occurred to the date of objective disease progression or death, whichever occurs first.
  measure: Overall Survival (OS)
  time frame: Baseline up to 3 years.
  description: From randomization to the time of death from any cause.
  measure: Adverse event rate
  time frame: Baseline up to 3 years.
  description: The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
  arm group label: Anlotinib group
  description: Anlotinib hydrochloride capsules: 12 mg once daily for 2 weeks, followed by a discontinuation of 1 week (21 days as a cycle)
  arm group label: Observation group
  description: Observation: prospectively and retrospectively collect data of patients who did not receive anlotinib hydrochloride capsules or similar small-molecule antivascular inhibitors.
  intervention type: Drug
  intervention name: Anlotinib Hydrochloride Capsule
  description: Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor that inhibits both tumor angiogenesis and tumor cell proliferation.
  arm group label: Anlotinib group
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Ming Gao, PhD
  phone: + 86 18622221110
  email: gaoming68@aliyun.com
  last name: Yansong Lin, PhD
  phone: +86 13671116837
  email: linys@pumch.cn
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Thyroid Neoplasms
  mesh term: Thyroid Diseases