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/NCT06010212</url>
    </required_header>
    <id_info>
      <org_study_id>2022-013-CH11 IIT-ESCC</org_study_id>
      <nct_id>NCT06010212</nct_id>
    </id_info>
    <brief_title>Fruquintinib as First Line Treatment in Patients With Recurrent Esophageal Squamous Cell Carcinoma</brief_title>
    <official_title>Fruquintinib Combined With Camrelizumab, Paclitaxel Liposome and Nedaplatin as First Line Treatment in Patients With Recurrent Esophageal Squamous Cell Carcinoma</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 Study is a Single-center, Single-arm, Phase II Clinical Study. The Primary Objective is&#xD;
        to Evaluate the Efficacy and Safety of Fruquintinib, Carrelizumab, Paclitaxel Liposomes&#xD;
        combined with Nidaplatin as First-line Treatment in Advanced Esophageal squamous cell&#xD;
        carcinoma .&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Not provided&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 25, 2023</start_date>
    <completion_date type="Anticipated">July 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2025</primary_completion_date>
    <phase>Phase 1/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>
      <intervention_model_description>Fruquintinib,Camrelizumab, Paclitaxel liposome combined with nedaplatin</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>ORR（Objective response rate）</measure>
      <time_frame>1 year</time_frame>
      <description>Objective Response Rate (ORR) is defined as the percentage of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. CR = disappearance of all target lesions, PR is =&gt;30% decrease in sum of diameters of target lesions.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>DCR（Disease control rates）</measure>
      <time_frame>1 year</time_frame>
      <description>Disease Control Rate (DCR) is defined as the percentage of patients achieving a complete response (CR) or partial response (PR) or stable disease (SD) based on RECIST 1.1 criteria. CR = disappearance of all target lesions, PR is =&gt;30% decrease in sum of diameters of target lesions, progressive disease (PD) is &gt;20% increase in sum of diameters of target lesions, stable disease (SD) is &lt;30% decrease or &lt;20% increase in sum of diameters of target lesions.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PFS（Progression-free survival）</measure>
      <time_frame>1 year</time_frame>
      <description>PFS is defined as the proportion of patients without disease progression (PD or relapse from CR) or death due to any cause at 6 months. Disease progression will be assessed using RECIST (version 1.1). Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =&gt;30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is &gt;20% increase in sum of diameters of target lesions, Stable Disease (SD) is &lt;30% decrease or &lt;20% increase in sum of diameters of target lesions.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">36</enrollment>
    <condition>Esophageal Squamous Cell Carcinoma</condition>
    <arm_group>
      <arm_group_label>Treatment group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Fruquintinib,Camrelizumab, Paclitaxel liposome combined with nedaplatin</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Fruquintinib Combined With Camrelizumab, Paclitaxel Liposome and Nedaplatin</intervention_name>
      <description>Phase Ib: Patients with advanced ESCC will be enrolled in a 3+3 dose escalation fashion, with projected enrolment of between 9-18 patients to determine RP2D. Once the RP2D is confirmed, the study will proceed to phase II.&#xD;
  fruquintinib: 3 mg, 4 mg, or 5 mg qd p.o., 2 weeks and 1 week, every 3 weeks ( dose exploration phases were performed sequentially from the 4 mg group, refer to the study design section for specific protocols); Camrelizumab: 200 mg I.V D1, every 3 weeks for treatment cycles; Paclitaxel liposomes: 135 mg/m2 i.v d1, administered every 3 weeks, up to 6 cycles; Nidaplatin: 70 mg/m2 i.v d1, administered every 3 weeks, up to 6 cycles. Chemotherapy is used for up to 6 cycles, followed by maintenance therapy with fruquintinib + Camrelizumab until disease progression or intolerable toxicity.&#xD;
  Phase II: Up to a total of 30 patients with advanced ESCC will be enrolled.</description>
      <arm_group_label>Treatment group</arm_group_label>
      <other_name>Fruquintinib, Camrelizumab, Paclitaxel liposome combined with nedaplatin</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Voluntarily to join the study and sign the informed consent form;&#xD;
  &#xD;
            2. Male or female patients aged 18-70 years (inclusive);&#xD;
  &#xD;
            3. Histological or cytology-confirmed unresectable advanced or metastatic ESCC;&#xD;
  &#xD;
            4. Identify at least one measurable lesion that meets the requirements of Efficacy&#xD;
               Evaluation Criteria for Solid Tumors (RECIST) version 1.1; If a lesion that has&#xD;
               previously received local therapy (radiotherapy, ablation, vascular intervention,&#xD;
               etc.) is the only lesion, there must be a clear radiographic basis for disease&#xD;
               progression of that lesion;&#xD;
  &#xD;
            5. Previous systemic therapy for advanced ESCC;&#xD;
  &#xD;
            6. ECOG ≤2;&#xD;
  &#xD;
            7. Laboratory tests: neutrophil ≥ 1.5×109/L; platelets≥ 75×109/L; Hemoglobin≥ 90g/L;&#xD;
               Serum creatinine ≤ 1.5 times the upper limit of normal and creatinine clearance ≥ 60&#xD;
               ml/min; Urine protein &lt;2+; If the urine protein ≥ 2+, the 24-hour urine protein should&#xD;
               be &lt; 1 g; Alanine aminotransferase and glutamate aminotransferase ≤ 1.5 times the&#xD;
               upper limit of normal, or 3 times the upper limit of normal in the presence of liver&#xD;
               metastases≤; total bilirubin ≤ 1.5 times the upper limit of normal or 3 times the&#xD;
               upper limit of normal in the presence of liver metastases≤; albumin≥ 3.0 g/dL;&#xD;
               Coagulation function: prothrombin time (PT), international normalized ratio (INR) ≤&#xD;
               1.5x ULN;&#xD;
  &#xD;
            8. Female patients with negative urine or blood hCG (except menopause and hysterectomy),&#xD;
               female patients of childbearing age and their partners take effective contraceptive&#xD;
               measures during the trial and within 3 months after the end of the last dose (e.g.,&#xD;
               combination of hormones (including estrogen and progesterone) combined with ovulation&#xD;
               suppression, progestogen contraception combined with ovulation suppression,&#xD;
               intrauterine device, intrauterine hormone release system, bilateral tubal ligation,&#xD;
               vasectomy, avoidance of sexual behavior, etc.)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Known to be allergic to recombinant humanized PD-1 monoclonal antibody drugs and their&#xD;
               components, or known to be allergic to fruquintinib or paclitaxel liposomes or&#xD;
               nidaplatin components;&#xD;
  &#xD;
            2. Have a second tumor within the past 5 years, except cured basal cell carcinoma of the&#xD;
               skin or squamous cell carcinoma of the skin or carcinoma in situ of any other site;&#xD;
  &#xD;
            3. Uncontrolled serious medical diseases that the investigator believes will affect the&#xD;
               patient's ability to receive treatment with the study protocol, such as serious&#xD;
               medical diseases, including severe heart disease, cerebrovascular disease,&#xD;
               uncontrolled diabetes, uncontrolled infection, etc.;&#xD;
  &#xD;
            4. The patient currently has gastrointestinal diseases such as active gastric and&#xD;
               duodenal ulcer and ulcerative colitis, or active bleeding in unremoved tumors, or&#xD;
               other conditions that may cause gastrointestinal bleeding and perforation as&#xD;
               determined by the investigator; or those who have previously had gastrointestinal&#xD;
               perforation or gastrointestinal fistula, which has not recovered after surgical&#xD;
               treatment;&#xD;
  &#xD;
            5. Patients with evidence of bleeding tendency or history (such as melena, hematemesis,&#xD;
               hemoptysis, bloody stools, etc.) within 2 months before the first dose;&#xD;
  &#xD;
            6. During screening, it was found that the tumor invaded the structure of large vessels,&#xD;
               such as pulmonary artery, superior vena cava or inferior vena cava, etc., and the&#xD;
               investigator judged that there was a greater risk of bleeding;&#xD;
  &#xD;
            7. History of arterial thrombosis or deep vein thrombosis within 6 months before the&#xD;
               first dose; or a stroke event and/or transient ischaemic attack within 12 months;&#xD;
               Thrombosis due to implantable intravenous infusion pump or catheter-derived&#xD;
               thrombosis, or superficial vein thrombosis, except for those with stable thrombosis&#xD;
               after conventional anticoagulation therapy;&#xD;
  &#xD;
            8. Receiving chemotherapy, targeting, immunotherapy, clinical trials, etc. of other&#xD;
               investigational drugs within 4 weeks before the administration of the first treatment;&#xD;
  &#xD;
            9. Patients previously diagnosed with coronary heart disease or ischemic cerebrovascular&#xD;
               disease;&#xD;
  &#xD;
           10. Pregnant or lactating female patients;&#xD;
  &#xD;
           11. Have any other disease, metabolic disorder, abnormal result of physical examination or&#xD;
               laboratory test and have reason to suspect that may contraindicate the use of the test&#xD;
               drug, or affect the reliability of the results of the study;&#xD;
  &#xD;
           12. Undergone major surgery within 28 days before the first dose, or received radiotherapy&#xD;
               within 14 days before the first dose, or used radiation agents (strontium, samarium,&#xD;
               etc.) within 56 days before the first dose;&#xD;
  &#xD;
           13. Judged by the investigator to be unsuitable to participate in this study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Yanhong Gu</last_name>
      <role>Principal Investigator</role>
      <affiliation>The First Affiliated Hospital with Nanjing Medical University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Tianzhu Qiu</last_name>
      <phone>18013873919</phone>
      <email>tianzhu_qiu@n.jmu.edu.cn</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Fruquintinib ，Carrelizumab，Advanced ESCC</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>Paclitaxel</mesh_term>
      <mesh_term>Albumin-Bound Paclitaxel</mesh_term>
      <mesh_term>Nedaplatin</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Plan to publish papers in 2025.</ipd_description>
    </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/NCT06010212
  org study id: 2022-013-CH11 IIT-ESCC
  nct id: NCT06010212
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This Study is a Single-center, Single-arm, Phase II Clinical Study. The Primary Objective is
        to Evaluate the Efficacy and Safety of Fruquintinib, Carrelizumab, Paclitaxel Liposomes
        combined with Nidaplatin as First-line Treatment in Advanced Esophageal squamous cell
        carcinoma .
  Not provided
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Fruquintinib,Camrelizumab, Paclitaxel liposome combined with nedaplatin
  primary purpose: Treatment
  masking: None (Open Label)
  measure: ORR（Objective response rate）
  time frame: 1 year
  description: Objective Response Rate (ORR) is defined as the percentage of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions.
  measure: DCR（Disease control rates）
  time frame: 1 year
  description: Disease Control Rate (DCR) is defined as the percentage of patients achieving a complete response (CR) or partial response (PR) or stable disease (SD) based on RECIST 1.1 criteria. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions.
  measure: PFS（Progression-free survival）
  time frame: 1 year
  description: PFS is defined as the proportion of patients without disease progression (PD or relapse from CR) or death due to any cause at 6 months. Disease progression will be assessed using RECIST (version 1.1). Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is >20% increase in sum of diameters of target lesions, Stable Disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions.
  arm group label: Treatment group
  arm group type: Experimental
  description: Fruquintinib,Camrelizumab, Paclitaxel liposome combined with nedaplatin
  intervention type: Drug
  intervention name: Fruquintinib Combined With Camrelizumab, Paclitaxel Liposome and Nedaplatin
  description: Phase Ib: Patients with advanced ESCC will be enrolled in a 3+3 dose escalation fashion, with projected enrolment of between 9-18 patients to determine RP2D. Once the RP2D is confirmed, the study will proceed to phase II.
  fruquintinib: 3 mg, 4 mg, or 5 mg qd p.o., 2 weeks and 1 week, every 3 weeks ( dose exploration phases were performed sequentially from the 4 mg group, refer to the study design section for specific protocols); Camrelizumab: 200 mg I.V D1, every 3 weeks for treatment cycles; Paclitaxel liposomes: 135 mg/m2 i.v d1, administered every 3 weeks, up to 6 cycles; Nidaplatin: 70 mg/m2 i.v d1, administered every 3 weeks, up to 6 cycles. Chemotherapy is used for up to 6 cycles, followed by maintenance therapy with fruquintinib + Camrelizumab until disease progression or intolerable toxicity.
  Phase II: Up to a total of 30 patients with advanced ESCC will be enrolled.
  arm group label: Treatment group
  other name: Fruquintinib, Camrelizumab, Paclitaxel liposome combined with nedaplatin
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Yanhong Gu
  role: Principal Investigator
  affiliation: The First Affiliated Hospital with Nanjing Medical University
  last name: Tianzhu Qiu
  phone: 18013873919
  email: tianzhu_qiu@n.jmu.edu.cn
  responsible party type: Sponsor
  mesh term: Carcinoma
  mesh term: Carcinoma, Squamous Cell
  mesh term: Esophageal Squamous Cell Carcinoma
  mesh term: Paclitaxel
  mesh term: Albumin-Bound Paclitaxel
  mesh term: Nedaplatin
  sharing ipd: No
  ipd description: Plan to publish papers in 2025.