<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/NCT04490421</url>
  </required_header>
  <id_info>
    <org_study_id>OBU-FJ-SCLC-II-005</org_study_id>
    <nct_id>NCT04490421</nct_id>
  </id_info>
  <brief_title>Camrelizumab Combined With Apatinib, Etoposide and Cisplatin Treat Small-cell Lung Cancer.</brief_title>
  <official_title>A Single-arm, Prospective Study of Camrelizumab Combined With Apatinib, Etoposide and Cisplatin in First-line Treatment of Extensive Small-cell Lung Cancer.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fuzhou General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fuzhou General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Small cell lung cancer is a highly malignant tumor, and its first-line treatment has not&#xD;
      broken through platinum-containing dual-drug chemotherapy in the past 30 years. Because small&#xD;
      cell lung cancer has the characteristics of easy resistance after first-line chemotherapy,&#xD;
      increased difficulty in treatment after resistance, and poor efficacy of second-line&#xD;
      treatment, how to formulate a plan that can control tumor progression to the greatest extent&#xD;
      has become a hot issue in recent research. Recently, immunotherapy and targeted therapy have&#xD;
      made breakthrough progress in small cell lung cancer, but its efficacy still needs to be&#xD;
      further improved. As immune combined chemotherapy combined with targeted therapy first&#xD;
      achieved good results in other tumors, this study aims to explore a longer disease-free&#xD;
      survival time and higher overall survival rate of patients with small cell lung cancer&#xD;
      through immunotherapy combined with targeted therapy combined with chemotherapy. Program to&#xD;
      bring new hope to patients. At the same time, this study will evaluate the safety of the&#xD;
      program, explore the prognostic indicators that may exist in the treatment, and provide new&#xD;
      inspiration for subsequent patient selection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Anticipated">February 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2021</primary_completion_date>
  <phase>Phase 3</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>1-year overall survival rate(1-year OS%)</measure>
    <time_frame>up to 1-year</time_frame>
    <description>1-year OS%, determined by RECIST V1.1 standard which means proportion of outcome events occurring within one year from the start of the trial</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>progression-free survival(PFS)</measure>
    <time_frame>up to approximately 4-6 months</time_frame>
    <description>PFS, determined by RECIST V1.1 standard which means the time from the beginning of the organised clinical trial to the onset of tumors (in any aspect) or death due to any reason</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overall survival(OS)</measure>
    <time_frame>up to approximately 18 months</time_frame>
    <description>OS, determined by RECIST V1.1 standard which means the time from randomization of patients in clinical trials to death due to any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate(ORR)</measure>
    <time_frame>up to 1-year</time_frame>
    <description>ORR, determined by RECIST V1.1 standard which refers to the proportion of patients whose tumors have shrunk to a certain amount and maintained for a certain period of time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>disease control rate(DCR)</measure>
    <time_frame>up to 1-year</time_frame>
    <description>DCR, determined by RECIST V1.1 standard which refers to proportion of patients whose tumors have shrunk or stabilized for a certain period of time</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">45</enrollment>
  <condition>Lung Neoplasm</condition>
  <condition>Small Cell Lung Cancer</condition>
  <condition>PD-1 Inhibitors</condition>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental:Camrelizumab combined with Apatinib, Etoposide and Cisplatin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Camrelizumab combined with Apatinib, Etoposide and Cisplatin</intervention_name>
    <description>Camrelizumab combined with Apatinib, Etoposide and Cisplatin</description>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥18 years old and ≤75 years old, regardless of gender;&#xD;
&#xD;
          -  Extensive-stage small cell lung cancer confirmed by histology or pathology;&#xD;
&#xD;
          -  According to the RECIST V1.1 standard, there is at least one measurable lesion;&#xD;
&#xD;
          -  Patients who have not previously been treated for small cell lung cancer (immune,&#xD;
             targeted, chemotherapy, etc.);&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group's physical status score (ECOG PS) 0~1;&#xD;
&#xD;
          -  Expected survival period ≥ 3 months;&#xD;
&#xD;
          -  Women of childbearing age must undergo a serum pregnancy study within 2 weeks before&#xD;
             the first medication, and the result is negative. Female subjects of childbearing age&#xD;
             and male subjects whose partners are women of childbearing age must contraception&#xD;
             during the study and within 180 days after the last administration of the study drug;&#xD;
&#xD;
          -  The laboratory examination values of patients before medication must meet the&#xD;
             following standards:&#xD;
&#xD;
        Blood routine: WBC≥3.0 × 109/L；ANC≥1.5 × 109/L；PLT≥100× 109/L；HGB≥9.0 g/dL; Liver function:&#xD;
        TBIL≤1.5 × ULN, AST≤2.5 × ULN, ALT≤2.5 × ULN (for subjects with liver metastases,&#xD;
        AST≤5×ULN, ALT≤5 × ULN) Renal function: Cr≤1.5 × ULN or CrCl ≥50 mL/min Coagulation&#xD;
        function: INR≤1.5, APTT≤1.5 ×ULN&#xD;
&#xD;
          -  The subjects voluntarily joined the study, signed an informed consent form, had good&#xD;
             compliance, and cooperated with the follow-up.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active, known or suspected autoimmune diseases;&#xD;
&#xD;
          -  Prior T cell co-stimulation or immunocheckpoint therapy, including but not limited to&#xD;
             CTLA-4 inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors or other T-cell-targeted drugs;&#xD;
&#xD;
          -  Interstitial lung disease, drug-induced pneumonia, radioactive pneumonia requiring&#xD;
             steroid treatment or active pneumonia with clinical symptoms or severe pulmonary&#xD;
             dysfunction;&#xD;
&#xD;
          -  A past or present history of cancer other than SCLC, except for non-melanoma skin&#xD;
             cancer, cervical cancer in situ, or other cancers that have received curative&#xD;
             treatment and have not shown signs of recurrence for at least 5 years;&#xD;
&#xD;
          -  Standard treatment for uncontrolled hypertension (blood pressure &lt; 150/90 mmHg)&#xD;
&#xD;
          -  Hereditary bleeding tendency or coagulation dysfunction. There were clinically&#xD;
             significant bleeding symptoms or definite bleeding tendency within 3 months before&#xD;
             enrollment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, and fecal&#xD;
             occult blood ++ or above at baseline;&#xD;
&#xD;
          -  Patients with definite or suspected brain metastases. Patients with a history of brain&#xD;
             metastases must have completed treatment and no longer require corticosteroid therapy&#xD;
             to be enrolled; For asymptomatic patients with no more than 3 lesions and a single&#xD;
             brain transfer less than 10mm, the researcher judged whether they were included or&#xD;
             not.&#xD;
&#xD;
          -  Clinical symptoms or diseases of the heart that are not well controlled, such as&#xD;
             :heart failure of NYHA2 or above; unstable angina pectoris; myocardial infarction&#xD;
             within 24 weeks; clinically significant supraventricular or ventricular arrhythmia&#xD;
             requiring treatment or intervention;&#xD;
&#xD;
          -  The presence of clinically uncontrollable third interstitial effusion (such as pleural&#xD;
             effusion/pericardial effusion, patients who do not need drainage or have no&#xD;
             significant increase of effusion after 3 days of drainage can be enrolled);&#xD;
&#xD;
          -  Subjects with a history of severe infection within 4 weeks prior to the first&#xD;
             administration, including but not limited to infectious complications requiring&#xD;
             hospitalization, bacteremia, severe pneumonia, etc. Subjects with any active infection&#xD;
             were excluded. Lymphatic spread of lung cancer was not excluded.&#xD;
&#xD;
          -  Imaging (CT or MRI) shows that the tumor invades the great vessels or the researchers&#xD;
             judge that the tumor is likely to invade the important vessels and cause fatal&#xD;
             hemorrhage during the follow-up study;&#xD;
&#xD;
          -  A history of immunodeficiency, including HIV positive, or other acquired or congenital&#xD;
             immunodeficiency diseases, or a history of organ transplantation and allogeneic bone&#xD;
             marrow transplantation;&#xD;
&#xD;
          -  Active hepatitis B (defined as hepatitis B virus surface antigen [HBsAg] test positive&#xD;
             and hbV-DNA test value higher than the upper limit of normal value in the laboratory&#xD;
             of the research center) or Hepatitis C (defined as hepatitis C virus surface antibody&#xD;
             [HCsAb] test positive and HCV-RNA positive);&#xD;
&#xD;
          -  Subjects requiring systematic treatment with corticosteroids (&gt;10 mg/ day prednisone&#xD;
             or its equivalent) or other immunosuppressive agents within 14 days of the first&#xD;
             administration. Adrenal hormone replacement therapy with inhaled or topical&#xD;
             corticosteroids and &gt; 10 mg/ day dose of prednisone in the absence of active&#xD;
             autoimmune disease;&#xD;
&#xD;
          -  Patients who received oral or intravenous antibiotics within 14 days before treatment;&#xD;
&#xD;
          -  The patient has an allergic reaction to the experimental drug;&#xD;
&#xD;
          -  Subjects who have received or will receive live vaccine within 30 days before the&#xD;
             first medication;&#xD;
&#xD;
          -  As determined by the researcher, the subjects have other factors that may lead to the&#xD;
             forced termination of the study.&#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>Xiong Chen</last_name>
    <role>Study Chair</role>
    <affiliation>The 900th Hospital of Joint Logistic Support Force</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xiong Chen</last_name>
    <phone>13625082108</phone>
    <phone_ext>+86</phone_ext>
    <email>zpccx81@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>The 900th Hospital of Joint Logistic Support Force</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <zip>350025</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiong Chen</last_name>
      <phone>13625082108</phone>
      <email>zpccx81@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>February 3, 2021</last_update_submitted>
  <last_update_submitted_qc>February 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Small-cell lung cancer, immunotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Small Cell Lung Carcinoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Etoposide</mesh_term>
    <mesh_term>Apatinib</mesh_term>
  </intervention_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/NCT04490421
org study id: OBU-FJ-SCLC-II-005
nct id: NCT04490421
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Small cell lung cancer is a highly malignant tumor, and its first-line treatment has not
      broken through platinum-containing dual-drug chemotherapy in the past 30 years. Because small
      cell lung cancer has the characteristics of easy resistance after first-line chemotherapy,
      increased difficulty in treatment after resistance, and poor efficacy of second-line
      treatment, how to formulate a plan that can control tumor progression to the greatest extent
      has become a hot issue in recent research. Recently, immunotherapy and targeted therapy have
      made breakthrough progress in small cell lung cancer, but its efficacy still needs to be
      further improved. As immune combined chemotherapy combined with targeted therapy first
      achieved good results in other tumors, this study aims to explore a longer disease-free
      survival time and higher overall survival rate of patients with small cell lung cancer
      through immunotherapy combined with targeted therapy combined with chemotherapy. Program to
      bring new hope to patients. At the same time, this study will evaluate the safety of the
      program, explore the prognostic indicators that may exist in the treatment, and provide new
      inspiration for subsequent patient selection.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 1-year overall survival rate(1-year OS%)
time frame: up to 1-year
description: 1-year OS%, determined by RECIST V1.1 standard which means proportion of outcome events occurring within one year from the start of the trial
measure: progression-free survival(PFS)
time frame: up to approximately 4-6 months
description: PFS, determined by RECIST V1.1 standard which means the time from the beginning of the organised clinical trial to the onset of tumors (in any aspect) or death due to any reason
measure: overall survival(OS)
time frame: up to approximately 18 months
description: OS, determined by RECIST V1.1 standard which means the time from randomization of patients in clinical trials to death due to any cause.
measure: Objective Response Rate(ORR)
time frame: up to 1-year
description: ORR, determined by RECIST V1.1 standard which refers to the proportion of patients whose tumors have shrunk to a certain amount and maintained for a certain period of time
measure: disease control rate(DCR)
time frame: up to 1-year
description: DCR, determined by RECIST V1.1 standard which refers to proportion of patients whose tumors have shrunk or stabilized for a certain period of time
arm group label: Experimental
arm group type: Experimental
description: Experimental:Camrelizumab combined with Apatinib, Etoposide and Cisplatin
intervention type: Drug
intervention name: Camrelizumab combined with Apatinib, Etoposide and Cisplatin
description: Camrelizumab combined with Apatinib, Etoposide and Cisplatin
arm group label: Experimental
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Xiong Chen
role: Study Chair
affiliation: The 900th Hospital of Joint Logistic Support Force
last name: Xiong Chen
phone: 13625082108
phone ext: +86
email: zpccx81@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Small Cell Lung Carcinoma
mesh term: Etoposide
mesh term: Apatinib
sharing ipd: Undecided