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/NCT05989425</url>
    </required_header>
    <id_info>
      <org_study_id>HMPL-012-SPRING-T102</org_study_id>
      <nct_id>NCT05989425</nct_id>
    </id_info>
    <brief_title>Surufatinib as Neoadjuvant Treatment for Locally Advanced or Metastatic Differentiated Thyroid Cancer</brief_title>
    <official_title>Surufatinib as Neoadjuvant Treatment for Locally Advanced or Metastatic Differentiated Thyroid Cancer: an Open-label, Multicenter, Single-arm Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fudan University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fudan 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>
        Locally advanced thyroid cancer has a wide range of surgery, large trauma and high local&#xD;
        recurrence rate. It is one of the main causes of death in patients with thyroid cancer.&#xD;
        Therefore, more effective treatments are urgently needed. This study is designed to evaluate&#xD;
        the efficacy and safety of the Surufatinib for Locally Advanced Thyroid Cancer.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 4, 2023</start_date>
    <completion_date type="Anticipated">August 4, 2026</completion_date>
    <primary_completion_date type="Anticipated">August 4, 2026</primary_completion_date>
    <phase>Phase 2</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>ORR</measure>
      <time_frame>approximately 1 years</time_frame>
      <description>Objective Response Rate</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>R0/1 resection rate</measure>
      <time_frame>approximately 1 years</time_frame>
      <description>R0 and R1 resection rate reviewed by operation team and pathologists R0 and R1 resection rate reviewed by operation team and pathologists R0 and R1 resection rate reviewed by operation team and pathologists dR0 and R1 resection rate reviewed by operation team and pathologists R0 and R1 resection rate reviewed by operation team and pathologists R0 and R1 resection rate reviewed by operation team and pathologists dvxddR0 and R1 resection rate reviewed by operation team and pathologists</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>DCR</measure>
      <time_frame>approximately 1 years</time_frame>
      <description>Disease Control Rate</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PFS</measure>
      <time_frame>approximately 1 years</time_frame>
      <description>Progression Free Survival</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AE</measure>
      <time_frame>From first dose to within 30 days after the last dose</time_frame>
      <description>Adverse Events</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">32</enrollment>
    <condition>Differentiated Thyroid Cancer</condition>
    <arm_group>
      <arm_group_label>surufatinib</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Surufatinib 300mg will be taken orally once daily continuously through a 28-day cycle of study treatment. After treatment, the patients will receive operation treatment if the tumor is evaluated as resectable cases by clinical examination. Patients with high risk of postoperative recurrence will receive 131I treatment. After 131I treatment, maintenance treatment with surufatinib will be determined according to the recurrence risk stratification.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>surufatinib</intervention_name>
      <description>Surufatinib is a tablet in the form of 50mg, oral, once a day.</description>
      <arm_group_label>surufatinib</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Locally advanced or metastatic thyroid cancer confirmed by histology or cytology,&#xD;
               including papillary thyroid carcinoma, follicular thyroid carcinoma, poorly&#xD;
               differentiated thyroid cancer, particularly differentiated thyroid cancer. Locally&#xD;
               advanced stage refers to: 1) Primary tumor with invasion or adhesion of organs and&#xD;
               structures, such as recurrent laryngeal nerve, esophagus, trachea, larynx,&#xD;
               encirclement of neck large vessels, mediastinal vessels, extensive invasion of skin,&#xD;
               subcutaneous soft tissue or neck muscles; 2). AJCC T4 Stage; 3). Difficult to achieve&#xD;
               R0/R1 resection during preoperative assessment;&#xD;
  &#xD;
            -  Age 14-75 years;&#xD;
  &#xD;
            -  At least one measurable lesion (RECIST 1.1);&#xD;
  &#xD;
            -  Eastern Cooperative Oncology Group (ECOG) score 0-1;&#xD;
  &#xD;
            -  Expected survival time ≥ 12 weeks;&#xD;
  &#xD;
            -  The main organ functions meet the following criteria: Absolute neutrophil value (ANC)&#xD;
               ≥ 1.5 × 109 / L; Platelet (PLT) ≥80 × 109 / L; Hemoglobin (HB) ≥9g / dL; White blood&#xD;
               cell count&gt; 1.5 × 109 / L; Total bilirubin (TBIL) ≤ 1.5 times the upper limit of&#xD;
               normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase&#xD;
               (AST) ≤ 2.5 ULN, if with liver metastases, ALT and AST ≤ 5 ULN; Serum creatinine (Cr)&#xD;
               ≤ 1.5 ULN or creatinine clearance (CCr) ≥ 50ml / min;&#xD;
  &#xD;
            -  Subjects of potential fertility are required to use at least one medically approved&#xD;
               contraceptive method (such as an intrauterine device, contraceptive pill, or condom)&#xD;
               during the study treatment and for 180 days after the end of the study treatment; The&#xD;
               serum HCG test must be negative before the first medication.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Prior treatment with anti-angiogenic small molecule targeted drugs;&#xD;
  &#xD;
            -  Received other anti-tumor therapy (including but not limited to chemotherapy,&#xD;
               radiotherapy, etc.) within 4 weeks prior to treatment, except for TSH suppression&#xD;
               treatment;&#xD;
  &#xD;
            -  Allergy to the study drug ;&#xD;
  &#xD;
            -  Have a history of serious cardiovascular and cerebrovascular diseases;&#xD;
  &#xD;
            -  Patients whose imaging showed that the tumor had invaded the important blood vessels&#xD;
               or the researchers judged that the tumor was likely to invade important blood vessels&#xD;
               during the subsequent study period and caused fatal bleeding;&#xD;
  &#xD;
            -  Patients with hypertension that cannot be well controlled by antihypertensive&#xD;
               medication (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg);&#xD;
  &#xD;
            -  The patient has had other malignant tumors within 5 years (except cured basal cell&#xD;
               carcinoma of the skin and carcinoma in situ of the cervix);&#xD;
  &#xD;
            -  The investigator considered that the subject was not suitable to participate in the&#xD;
               study due to any clinical or laboratory abnormalities or other reasons.&#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>Jiaying Chen</last_name>
      <role>Principal Investigator</role>
      <affiliation>Fudan University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Yu Wang</last_name>
      <role>Principal Investigator</role>
      <affiliation>Fudan University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jiaying Chen</last_name>
      <phone>86-18017317883</phone>
      <email>chen_lain@hotmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Yu Wang</last_name>
      <email>headneck@126.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Fudan University Shanghai Cancer Center</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>200032</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jiaying Chen</last_name>
        <phone>86-18017317883</phone>
        <email>chen_lain@hotmail.com</email>
      </contact>
      <contact_backup>
        <last_name>Yu Wang</last_name>
        <email>headneck@126.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 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 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Fudan University</investigator_affiliation>
      <investigator_full_name>Chen Jiaying</investigator_full_name>
      <investigator_title>Professor, Fudan University Shanghai Cancer</investigator_title>
    </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>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05989425
  org study id: HMPL-012-SPRING-T102
  nct id: NCT05989425
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Locally advanced thyroid cancer has a wide range of surgery, large trauma and high local
        recurrence rate. It is one of the main causes of death in patients with thyroid cancer.
        Therefore, more effective treatments are urgently needed. This study is designed to evaluate
        the efficacy and safety of the Surufatinib for Locally Advanced Thyroid Cancer.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: ORR
  time frame: approximately 1 years
  description: Objective Response Rate
  measure: R0/1 resection rate
  time frame: approximately 1 years
  description: R0 and R1 resection rate reviewed by operation team and pathologists R0 and R1 resection rate reviewed by operation team and pathologists R0 and R1 resection rate reviewed by operation team and pathologists dR0 and R1 resection rate reviewed by operation team and pathologists R0 and R1 resection rate reviewed by operation team and pathologists R0 and R1 resection rate reviewed by operation team and pathologists dvxddR0 and R1 resection rate reviewed by operation team and pathologists
  measure: DCR
  time frame: approximately 1 years
  description: Disease Control Rate
  measure: PFS
  time frame: approximately 1 years
  description: Progression Free Survival
  measure: AE
  time frame: From first dose to within 30 days after the last dose
  description: Adverse Events
  arm group label: surufatinib
  arm group type: Experimental
  description: Surufatinib 300mg will be taken orally once daily continuously through a 28-day cycle of study treatment. After treatment, the patients will receive operation treatment if the tumor is evaluated as resectable cases by clinical examination. Patients with high risk of postoperative recurrence will receive 131I treatment. After 131I treatment, maintenance treatment with surufatinib will be determined according to the recurrence risk stratification.
  intervention type: Drug
  intervention name: surufatinib
  description: Surufatinib is a tablet in the form of 50mg, oral, once a day.
  arm group label: surufatinib
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Jiaying Chen
  role: Principal Investigator
  affiliation: Fudan University
  last name: Yu Wang
  role: Principal Investigator
  affiliation: Fudan University
  last name: Jiaying Chen
  phone: 86-18017317883
  email: chen_lain@hotmail.com
  last name: Yu Wang
  email: headneck@126.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Fudan University
  investigator full name: Chen Jiaying
  investigator title: Professor, Fudan University Shanghai Cancer
  mesh term: Thyroid Neoplasms
  mesh term: Thyroid Diseases
  sharing ipd: No