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/NCT06020885</url>
    </required_header>
    <id_info>
      <org_study_id>GASTO-10102</org_study_id>
      <nct_id>NCT06020885</nct_id>
    </id_info>
    <brief_title>Fraction Dose Escalation of Split-course Hypofractionated Concurrent Chemoradiotherapy Following Induction Chemo-immunotherapy in Unresectable Locally Advanced Esophageal Squamous Carcinoma: a Phase I Study.</brief_title>
    <official_title>Fraction Dose Escalation of Split-course Hypofractionated Concurrent Chemoradiotherapy Following Induction Chemo-immunotherapy in Unresectable Locally Advanced Esophageal Squamous Carcinoma: a Phase I Study.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sun Yat-sen University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sun Yat-sen 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 Phase I study is to determine the maximum tolerated fraction dose (MTD) for split-course&#xD;
        hypo-CCRT following induction chemo-immunotherapy in LA-ESCC patients, to clarify the&#xD;
        dosimetric advantage of split-course hypo-CCRT, and to investigate the treatment-related&#xD;
        toxicities and quality of life of the new regimen.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This Phase I study is to determine the maximum tolerated fraction dose (MTD) for split-course&#xD;
        hypo-CCRT following induction chemo-immunotherapy in LA-ESCC patients, to clarify the&#xD;
        dosimetric advantage of split-course hypo-CCRT, and to investigate the treatment-related&#xD;
        toxicities and quality of life of the new regimen.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 31, 2024</primary_completion_date>
    <phase>Phase 1</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>Tolerated fraction dose</measure>
      <time_frame>6 months</time_frame>
      <description>Define the maximum tolerated fraction dose (MTD) for split-course hypo-CCRT following induction chemo-immunotherapy.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>2-year overall survival rate</measure>
      <time_frame>2-year</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>2-year progression-free survival rate</measure>
      <time_frame>2-year</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clinical response rate</measure>
      <time_frame>2 months after radiotherapy</time_frame>
      <description>The percentage of patients who had partial remission or complete remission after therapy</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The rate of grade 3 or 4 toxicities according to CTCAE5.0</measure>
      <time_frame>1 year after therapy</time_frame>
      <description>the percentage of patients who develop grade 3 or 4 toxicities</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">18</enrollment>
    <condition>Esophageal Squamous Cell Carcinoma</condition>
    <arm_group>
      <arm_group_label>Experiment group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This is a prospective, single-arm, phase 1 trial. A total of 18 unresectable LA-ESCC patients are required to be enrolled.&#xD;
  Induction chemo-immunotherapy All patients receive 2-3 cycles of Abraxane 260mg/m2 d1+cisplatin 60mg/m2 d1+Toripalimab 240mg d1.&#xD;
  Hypo-CCRT Evaluation will be performed three weeks after the induction chemo-immunotherapy, LA-ESCC patients without disease progression will continue the split-course hypo-CCRT treatment.&#xD;
  Split-course hypo-CCRT is administered at the following three dose levels:&#xD;
  Level 1: DT 3000cGy/10 daily fractions/300cGy in the first course, DT 2000cGy/10 daily fractions/200cGy in the second course;&#xD;
  Level 2: DT 2800cGy/7 daily fractions/400cGy in the first course, DT 2200cGy/10 daily fractions/220cGy in the second course;&#xD;
  Level 3: DT 2500cGy/5 daily fractions/500cGy in the first course, DT 2500cGy10 daily fractions/250cGy in the second course.</description>
    </arm_group>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>Split-course hypo-CCRT</intervention_name>
      <description>Split-course hypo-CCRT is administered at the following three dose levels:&#xD;
  Level 1: DT 3000cGy/10 daily fractions/300cGy in the first course, DT 2000cGy/10 daily fractions/200cGy in the second course;&#xD;
  Level 2: DT 2800cGy/7 daily fractions/400cGy in the first course, DT 2200cGy/10 daily fractions/220cGy in the second course;&#xD;
  Level 3: DT 2500cGy/5 daily fractions/500cGy in the first course, DT 2500cGy10 daily fractions/250cGy in the second course.</description>
      <arm_group_label>Experiment group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Induction chemo-immunotherapy</intervention_name>
      <description>All patients receive 2-3 cycles of Abraxane 260mg/m2 d1+cisplatin 60mg/m2 d1+Toripalimab 240mg d1.</description>
      <arm_group_label>Experiment group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Concurrent chemotherapy</intervention_name>
      <description>Concurrent capecitabine was administered orally at 1000mg/m2 twice daily within half an hour after meals concurrently with radiotherapy.</description>
      <arm_group_label>Experiment group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  histologically confirmed ESCC&#xD;
  &#xD;
            -  II-IVB stages (IVB stage only with metastatic celiac or supraclavicular lymph nodes)&#xD;
               based on the TNM staging system proposed by the International Union Against Cancer&#xD;
               (UICC 2002)&#xD;
  &#xD;
            -  Eastern Cooperative Oncology Group (ECOG) performance status score 0-1&#xD;
  &#xD;
            -  Charlson Comorbidity Index score≤4&#xD;
  &#xD;
            -  oral medication can be administered despite esophageal obstruction&#xD;
  &#xD;
            -  adequate hematological, renal and hepatic functions&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  contraindication for radiotherapy or chemotherapy&#xD;
  &#xD;
            -  prior malignancies, except for curable non-melanoma skin cancer or cervical carcinoma&#xD;
               in situ&#xD;
  &#xD;
            -  distant metastasis, except for celiac or supraclavicular lymph nodes metastases&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hui Liu, Professor</last_name>
      <role>Principal Investigator</role>
      <affiliation>Sun yat-sen universtiy cancer center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Bo Qiu, Professor</last_name>
      <phone>+86-020-87343031</phone>
      <email>qiubo@sysucc.org.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Sun yat-sen University Cancer Center</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <zip>510060</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Bo Qiu, Professor</last_name>
        <phone>+862087343031</phone>
        <email>qiubo@sysucc.org.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 26, 2023</last_update_submitted>
    <last_update_submitted_qc>August 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
      <investigator_full_name>Hui Liu</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Split-course hypofractionated concurrent chemoradiotherapy</keyword>
    <keyword>Fraction dose escalation</keyword>
    <keyword>Induction chemo-immunotherapy</keyword>
    <keyword>Unresectable locally advanced esophageal squamous carcinoma</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carcinoma</mesh_term>
      <mesh_term>Carcinoma, Squamous Cell</mesh_term>
      <mesh_term>Esophageal Squamous Cell Carcinoma</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Immunomodulating Agents</mesh_term>
    </intervention_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/NCT06020885
  org study id: GASTO-10102
  nct id: NCT06020885
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This Phase I study is to determine the maximum tolerated fraction dose (MTD) for split-course
        hypo-CCRT following induction chemo-immunotherapy in LA-ESCC patients, to clarify the
        dosimetric advantage of split-course hypo-CCRT, and to investigate the treatment-related
        toxicities and quality of life of the new regimen.
  This Phase I study is to determine the maximum tolerated fraction dose (MTD) for split-course
        hypo-CCRT following induction chemo-immunotherapy in LA-ESCC patients, to clarify the
        dosimetric advantage of split-course hypo-CCRT, and to investigate the treatment-related
        toxicities and quality of life of the new regimen.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Tolerated fraction dose
  time frame: 6 months
  description: Define the maximum tolerated fraction dose (MTD) for split-course hypo-CCRT following induction chemo-immunotherapy.
  measure: 2-year overall survival rate
  time frame: 2-year
  measure: 2-year progression-free survival rate
  time frame: 2-year
  measure: Clinical response rate
  time frame: 2 months after radiotherapy
  description: The percentage of patients who had partial remission or complete remission after therapy
  measure: The rate of grade 3 or 4 toxicities according to CTCAE5.0
  time frame: 1 year after therapy
  description: the percentage of patients who develop grade 3 or 4 toxicities
  arm group label: Experiment group
  arm group type: Experimental
  description: This is a prospective, single-arm, phase 1 trial. A total of 18 unresectable LA-ESCC patients are required to be enrolled.
  Induction chemo-immunotherapy All patients receive 2-3 cycles of Abraxane 260mg/m2 d1+cisplatin 60mg/m2 d1+Toripalimab 240mg d1.
  Hypo-CCRT Evaluation will be performed three weeks after the induction chemo-immunotherapy, LA-ESCC patients without disease progression will continue the split-course hypo-CCRT treatment.
  Split-course hypo-CCRT is administered at the following three dose levels:
  Level 1: DT 3000cGy/10 daily fractions/300cGy in the first course, DT 2000cGy/10 daily fractions/200cGy in the second course;
  Level 2: DT 2800cGy/7 daily fractions/400cGy in the first course, DT 2200cGy/10 daily fractions/220cGy in the second course;
  Level 3: DT 2500cGy/5 daily fractions/500cGy in the first course, DT 2500cGy10 daily fractions/250cGy in the second course.
  intervention type: Radiation
  intervention name: Split-course hypo-CCRT
  description: Split-course hypo-CCRT is administered at the following three dose levels:
  Level 1: DT 3000cGy/10 daily fractions/300cGy in the first course, DT 2000cGy/10 daily fractions/200cGy in the second course;
  Level 2: DT 2800cGy/7 daily fractions/400cGy in the first course, DT 2200cGy/10 daily fractions/220cGy in the second course;
  Level 3: DT 2500cGy/5 daily fractions/500cGy in the first course, DT 2500cGy10 daily fractions/250cGy in the second course.
  arm group label: Experiment group
  intervention type: Drug
  intervention name: Induction chemo-immunotherapy
  description: All patients receive 2-3 cycles of Abraxane 260mg/m2 d1+cisplatin 60mg/m2 d1+Toripalimab 240mg d1.
  arm group label: Experiment group
  intervention type: Drug
  intervention name: Concurrent chemotherapy
  description: Concurrent capecitabine was administered orally at 1000mg/m2 twice daily within half an hour after meals concurrently with radiotherapy.
  arm group label: Experiment group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Hui Liu, Professor
  role: Principal Investigator
  affiliation: Sun yat-sen universtiy cancer center
  last name: Bo Qiu, Professor
  phone: +86-020-87343031
  email: qiubo@sysucc.org.cn
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Sun Yat-sen University
  investigator full name: Hui Liu
  investigator title: Professor
  mesh term: Carcinoma
  mesh term: Carcinoma, Squamous Cell
  mesh term: Esophageal Squamous Cell Carcinoma
  mesh term: Immunomodulating Agents