<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/NCT04459078</url>
  </required_header>
  <id_info>
    <org_study_id>CAPAP-lung</org_study_id>
    <nct_id>NCT04459078</nct_id>
  </id_info>
  <brief_title>Clinical Study of Camrelizumab Combined With APatinib and Albumin Paclitacxel in Patients With Advanced Lung Adenocarcinoma</brief_title>
  <official_title>A Prospective Single-arm Phase II Clinical Study to Evaluate the Efficacy of Camrelizumab in Combined With APatinib and Albumin Paclitacxel in Advanced Untreated EGFR Wild Type and ALK-negative Lung Adenocarcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hunan Cancer Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Suzhou Sheng Diya Biomedical Co., Ltd.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hunan Cancer 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>
      This study is a single arm, open label, national multicenter study, to explore the efficacy&#xD;
      and safety of the combination of Camrelizumab, apatinib and albumin paclitaxel in advanced&#xD;
      untreated EGFR Wild Type and ALK-negative Lung Adenocarcinoma. The study does not consider&#xD;
      PD-L1 expression, but tumor samples need to be explored by PD-L1 detection and other&#xD;
      exploratory analysis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary outcome:&#xD;
&#xD;
      1. progression free survival (PFS) evaluated according to RECIST1.1.&#xD;
&#xD;
      Secondary outcome:&#xD;
&#xD;
        1. Objective Response Rate (ORR), Overall Survival (OS), Disease Control Rate (DCR),&#xD;
           Duration of Response (DOR) evaluated according to RECIST1.1, and Quality of Life(QOL).&#xD;
&#xD;
        2. The overall incidence of adverse events (AE); the incidence of grade 3 or above AE; the&#xD;
           incidence of serious adverse events (SAE); the incidence of AE leading to the&#xD;
           termination of the trial drug; the incidence of AE leading to the suspension of the&#xD;
           trial drug.&#xD;
&#xD;
        3. Exploratory analysis of potential biomarkers related to efficacy. The characteristics of&#xD;
           tumor tissue PD-L1expression, panel-captured next generation sequencing(NGS), RNA-seq,&#xD;
           T-Cell Repertoire (TCR), multiple immunofluorescence and other biomarkers, and the&#xD;
           correlation analysis of biomarkers with efficacy and safety.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 26, 2020</start_date>
  <completion_date type="Anticipated">July 15, 2023</completion_date>
  <primary_completion_date type="Anticipated">May 15, 2023</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>
    <intervention_model_description>Patients fulfilling Eligibility Criteria will be enrolled into our study. Participants are given intravenous administration of Camrelizumab (200mg/3w) in addition with intravenous administration of Albumin Paclitacxel (135mg/m2, d1, d8/3w, 4-6 cycles) and Apatinib (250mg Qd po for 5 days, take rest for 2 days every week). Treatment terminates when disease progression, death or unacceptable toxicity</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PFS</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Progression free survival (PFS) evaluated by investigators based on the RECIST 1.1 criteria.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ORR</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Objective Remission Rate (ORR) evaluated by researchers based on the RECIST 1.1 criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OS</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Overall Survival (OS) evaluated by researchers based on the RECIST 1.1 criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DCR</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Disease Control Rate（DCR）evaluated by researchers based on the RECIST 1.1 criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DOR</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Duration of Response (DOR) evaluated by researchers based on the RECIST 1.1 criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change of quality of life</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>The change of quality of life is measured using the European Organization for Reasearch and Treatment of Cancer Quality of Life Questionnaire（EORTC QLQ）</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AE</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>The overall incidence of adverse events (AE); the incidence of grade 3 or above AE; the incidence of serious adverse events (SAE); the incidence of AE leading to the termination of the trial drug; the incidence of AE leading to the suspension of the trial drug</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">63</enrollment>
  <condition>Adenocarcinoma of the Lung</condition>
  <arm_group>
    <arm_group_label>Camrelizumab combined with Albumin Paclitacxel and Apatinib.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants are given intravenous administration of Camrelizumab (200mg/3w) in addition with intravenous administration of Albumin Paclitacxel (135mg/m2, d1, d8/3w, 4-6 cycles) and Apatinib (250mg Qd po for 5 days,, take rest for 2 days every week). Treatment terminates when disease progression, death or unacceptable toxicity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Camrelizumab</intervention_name>
    <description>Intravenous administration of (200mg/3weeks)</description>
    <arm_group_label>Camrelizumab combined with Albumin Paclitacxel and Apatinib.</arm_group_label>
    <other_name>SHR1210</other_name>
    <other_name>PD-1 inhibitor</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Albumin Paclitacxel</intervention_name>
    <description>intravenous administration of Albumin Paclitacxel (135mg/m2, d1, d8/3w, 4-6 cycles)</description>
    <arm_group_label>Camrelizumab combined with Albumin Paclitacxel and Apatinib.</arm_group_label>
    <other_name>Chemotherapy drug</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Apatinib</intervention_name>
    <description>Patients will be given oral of Apatinib (250mg Qd po for 5 days, take rest for 2 days every week)</description>
    <arm_group_label>Camrelizumab combined with Albumin Paclitacxel and Apatinib.</arm_group_label>
    <other_name>Anti-angiogenesis drug</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. Age&gt;=18 years, both men and women can be enrolled 2. Histologically confirmed&#xD;
             adenocarcinoma (does not contain small cell components).&#xD;
&#xD;
             3. Locally advanced, untreated recurrent or metastatic lung adenocarcinoma not&#xD;
             suitable for radical surgery or radiotherapy. Previous neoadjuvant and adjuvant&#xD;
             radiochemotherapy can be accepted (chemotherapy/radiotherapy, non-immunotherapy),&#xD;
             tumor progression ≥6 months before the end of neoadjuvant / adjuvant therapy is&#xD;
             required .&#xD;
&#xD;
             4. ECOG score of physical condition was 0-1, and there was no deterioration in the&#xD;
             first 2 weeks. Expected survival over 12 weeks.&#xD;
&#xD;
             5. According to the RECIST1.1 criteria, it is required that at least one measurable&#xD;
             treatment naive lesion (has not been treated with radiotherapy in the past and will&#xD;
             not receive local therapy such as radiotherapy throughout the treatment); If the&#xD;
             lesion has been treated with radiotherapy then the progress of this lesion need to be&#xD;
             confirmed by imaging, before being used as the target lesion.&#xD;
&#xD;
             6. Laboratory certified by CAP reported negative in EGFR and ALK mutation-sensitive&#xD;
             mutations.&#xD;
&#xD;
             7. Clinical laboratory examination indicators meet the following standards:&#xD;
&#xD;
               1. Platelet ≥100×109/L&#xD;
&#xD;
               2. Absolute neutrophil count (ANC) ≥1.5×109/L, or absolute white blood cell count&#xD;
                  (WBC) ≥3.5×109/L&#xD;
&#xD;
               3. Hemoglobin (Hgb) ≥ 100 g/L (without blood transfusion or erythropoietin use&#xD;
                  within 4 weeks)&#xD;
&#xD;
               4. Total bilirubin ≤ 1.5 times the upper limit of normal value (ULN) (If there is&#xD;
                  liver metastasis, allow ≤2.5 times ULN)&#xD;
&#xD;
               5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times&#xD;
                  ULN&#xD;
&#xD;
               6. Creatinine ≤1.5 times ULN or Creatinine clearance ≥50 mL/min (Calculated&#xD;
                  according to the Cockcroft Gault formula)&#xD;
&#xD;
               7. Serum amylase ≤ 2 times ULN or pancreatic amylase ≤ 1.5 times ULN&#xD;
&#xD;
               8. Serum lipase ≤ 1.5 times ULN&#xD;
&#xD;
               9. patients who did not take anticoagulants, or those who had previously used&#xD;
                  anticoagulants, had been discontinued for 28 days before enrollment, and the&#xD;
                  international normalized ratio (INR) ≤ 1.5 and activated partial thromboplastin&#xD;
                  time (APTT) ≤ 1.5 times ULN.&#xD;
&#xD;
                  8. Able to swallow oral medication. 9. Enough tissue specimens for PD-L1&#xD;
                  detection or exploratory analysis.&#xD;
&#xD;
                  Exclusion Criteria:&#xD;
&#xD;
          -  1.The histological component of NSCLC containing small cell lung cancer or squamous&#xD;
             cell carcinoma was excluded.&#xD;
&#xD;
             2. Previously untreated or symptomatic central nervous system (CNS) metastases or&#xD;
             meningeal diseases, spinal cord compression, meningeal metastases and brain metastases&#xD;
             with obvious symptoms, etc. For those who have received radiotherapy and/or surgery,&#xD;
             patients with no evidence of CNS disease progression ≥ 2 weeks after the end of&#xD;
             treatment, patients who had not been treated with corticosteroids for more than 2&#xD;
             weeks before the start of treatment were eligible.&#xD;
&#xD;
             3. Clinically significant hemoptysis (at least 0.5 teaspoons of fresh blood) or tumor&#xD;
             bleeding occurred within 2 weeks before the first dose of study treatment.&#xD;
&#xD;
             4. There is imaging evidence of invasion/infiltration of large vessels. Due to the&#xD;
             potential risk of severe bleeding associated with tumor shrinkage/necrosis after&#xD;
             apatinib treatment, the degree of tumor invasion/infiltration of major blood vessels&#xD;
             should be considered.&#xD;
&#xD;
             5. Cancerous thrombus with clinical significance, and the use of anticoagulant drugs&#xD;
             within 28 days before enrollment.&#xD;
&#xD;
             6. Clinically uncontrollable pleural effusion/abdominal effusion. 7. Glucocorticoid&#xD;
             treatment 28 days before the first dose (equivalent dose of &gt;10 mg prednisone per&#xD;
             day).&#xD;
&#xD;
             8. Having active autoimmune diseases, which require systemic treatment in the past 2&#xD;
             years (ie using disease-modifying drugs, corticosteroids or immunosuppressive drugs).&#xD;
             Replacement therapy (for example, thyroxine, insulin, or physiological corticosteroid&#xD;
             replacement therapy due to adrenal or pituitary insufficiency, etc.) is not considered&#xD;
             as systemic therapy and is allowed.&#xD;
&#xD;
             9. History of other malignant tumors in the past 5 years. 10. Has received previous&#xD;
             systemic chemotherapy or other targeted or biological anti-tumor treatment for its&#xD;
             metastatic NSCLC (As long as treatment is completed at least 6 months before diagnosis&#xD;
             of metastatic NSCLC, prior chemotherapy and/or radiotherapy is allowed as part of&#xD;
             neoadjuvant/adjuvant therapy for non-metastatic NSCLC).&#xD;
&#xD;
             11. Previously received anti-PD-1, anti-PD-L1, anti-PD-L2 and other drugs or drugs&#xD;
             acting on another stimulatory or co-suppressive T cell receptor (eg CTLA-4, OX 40,&#xD;
             CD137 ) therapy, or cell biological therapy, etc.&#xD;
&#xD;
             12. Previously received treatment with apatinib, or received systemic medication with&#xD;
             a clear anti-tumor mechanism.&#xD;
&#xD;
             13. Allogeneic tissue/solid organ transplantation has been performed. 14. In addition&#xD;
             to hair loss and stable peripheral neurotoxicity below grade 2, any clinical toxicity&#xD;
             associated with prior treatment before enrollment did not return to pre-treatment&#xD;
             levels or grade 1.&#xD;
&#xD;
             15. pregnancy status (positive blood HCG) and lactation. 16. Previously suffering from&#xD;
             interstitial lung disease, drug-induced interstitial lung disease, radiation&#xD;
             pneumonitis requiring hormone therapy, or any active interstitial lung disease with&#xD;
             clinical evidence.&#xD;
&#xD;
             17. Known liver diseases of clinical significance, including active viral hepatitis,&#xD;
             alcoholic hepatitis or other hepatitis, liver cirrhosis, hereditary liver disease.(&#xD;
             patients who have been cured of previous HBV infection (defined as hepatitis B core&#xD;
             antibody [HBcAb] positive and HBsAg negative) can participate in this study. Before&#xD;
             entering the group, HBV DNA testing must be performed on this class of patients and&#xD;
             well-controlled hepatitis B (peripheral HBV DNA testing is less than 103/ml) can be&#xD;
             considered for this experiment, and antiviral treatment should be given. Previous&#xD;
             patients infected with hepatitis C virus (HCV) had positive HCV antibody test results,&#xD;
             They were eligible for this study only if the HCV RNA polymerase chain reaction test&#xD;
             result was negative (below the detection limit).) 18. Patients who are suspected or&#xD;
             have demonstrated an impaired immune function or infection, including:&#xD;
&#xD;
               -  Evidence that active or latent tuberculosis (TB) is determined by locally&#xD;
                  approved screening methods. If the screening results require treatment in&#xD;
                  accordance with local treatment guidelines or clinical practice, the patient is&#xD;
                  disqualified.&#xD;
&#xD;
               -  Chronic or active hepatitis B or hepatitis C.&#xD;
&#xD;
               -  Known history of human immunodeficiency virus (HIV) infection. During the&#xD;
                  screening period, the local test result was positive.&#xD;
&#xD;
               -  There are any other medical conditions (such as active infections that have been&#xD;
                  treated or not treated) that the investigator believes that the patient has an&#xD;
                  unacceptable risk if receiving immunomodulatory therapy(Patients with local&#xD;
                  diseases that are unlikely to cause systemic infections (such as chronic nail&#xD;
                  fungal infections) are allowed to be enrolled).&#xD;
&#xD;
                  19. Allogeneic bone marrow or organ transplantation. 20. Any immunomodulator with&#xD;
                  systemic effects. 21. Known mental illness or substance abuse disorders that&#xD;
                  interfere with a subject's ability to comply with research requirements.&#xD;
&#xD;
                  22. Previous severe allergy to mAb treatment or known allergy or intolerance to&#xD;
                  any component of study medication (apatinib, caririzumab).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Fujian Cancer Hospital</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hunan Cancer hospital</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Kunming Medical University</name>
      <address>
        <city>Kunming</city>
        <state>Yunnan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>November 30, 2022</last_update_submitted>
  <last_update_submitted_qc>November 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hunan Cancer Hospital</investigator_affiliation>
    <investigator_full_name>Lin Wu</investigator_full_name>
    <investigator_title>Chief physician, director of department</investigator_title>
  </responsible_party>
  <keyword>immunotherapy</keyword>
  <keyword>PD-1 checkpoint inhibitor</keyword>
  <keyword>Anti-angiogenesis</keyword>
  <keyword>First-line Treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
    <mesh_term>Adenocarcinoma of Lung</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Apatinib</mesh_term>
    <mesh_term>Immune Checkpoint Inhibitors</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Data can be shared no earlier than 1 year following the date of publication</ipd_time_frame>
    <ipd_access_criteria>please contact the principal investigator of this study or correspondence author of published work.</ipd_access_criteria>
  </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/NCT04459078
org study id: CAPAP-lung
nct id: NCT04459078
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is a single arm, open label, national multicenter study, to explore the efficacy
      and safety of the combination of Camrelizumab, apatinib and albumin paclitaxel in advanced
      untreated EGFR Wild Type and ALK-negative Lung Adenocarcinoma. The study does not consider
      PD-L1 expression, but tumor samples need to be explored by PD-L1 detection and other
      exploratory analysis.
Primary outcome:

      1. progression free survival (PFS) evaluated according to RECIST1.1.

      Secondary outcome:

        1. Objective Response Rate (ORR), Overall Survival (OS), Disease Control Rate (DCR),
           Duration of Response (DOR) evaluated according to RECIST1.1, and Quality of Life(QOL).

        2. The overall incidence of adverse events (AE); the incidence of grade 3 or above AE; the
           incidence of serious adverse events (SAE); the incidence of AE leading to the
           termination of the trial drug; the incidence of AE leading to the suspension of the
           trial drug.

        3. Exploratory analysis of potential biomarkers related to efficacy. The characteristics of
           tumor tissue PD-L1expression, panel-captured next generation sequencing(NGS), RNA-seq,
           T-Cell Repertoire (TCR), multiple immunofluorescence and other biomarkers, and the
           correlation analysis of biomarkers with efficacy and safety.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Patients fulfilling Eligibility Criteria will be enrolled into our study. Participants are given intravenous administration of Camrelizumab (200mg/3w) in addition with intravenous administration of Albumin Paclitacxel (135mg/m2, d1, d8/3w, 4-6 cycles) and Apatinib (250mg Qd po for 5 days, take rest for 2 days every week). Treatment terminates when disease progression, death or unacceptable toxicity
primary purpose: Treatment
masking: None (Open Label)
measure: PFS
time frame: Up to 24 months
description: Progression free survival (PFS) evaluated by investigators based on the RECIST 1.1 criteria.
measure: ORR
time frame: Up to 24 months
description: Objective Remission Rate (ORR) evaluated by researchers based on the RECIST 1.1 criteria.
measure: OS
time frame: Up to 24 months
description: Overall Survival (OS) evaluated by researchers based on the RECIST 1.1 criteria.
measure: DCR
time frame: Up to 24 months
description: Disease Control Rate（DCR）evaluated by researchers based on the RECIST 1.1 criteria.
measure: DOR
time frame: Up to 24 months
description: Duration of Response (DOR) evaluated by researchers based on the RECIST 1.1 criteria.
measure: The change of quality of life
time frame: Up to 24 months
description: The change of quality of life is measured using the European Organization for Reasearch and Treatment of Cancer Quality of Life Questionnaire（EORTC QLQ）
measure: AE
time frame: Up to 24 months
description: The overall incidence of adverse events (AE); the incidence of grade 3 or above AE; the incidence of serious adverse events (SAE); the incidence of AE leading to the termination of the trial drug; the incidence of AE leading to the suspension of the trial drug
arm group label: Camrelizumab combined with Albumin Paclitacxel and Apatinib.
arm group type: Experimental
description: Participants are given intravenous administration of Camrelizumab (200mg/3w) in addition with intravenous administration of Albumin Paclitacxel (135mg/m2, d1, d8/3w, 4-6 cycles) and Apatinib (250mg Qd po for 5 days,, take rest for 2 days every week). Treatment terminates when disease progression, death or unacceptable toxicity.
intervention type: Drug
intervention name: Camrelizumab
description: Intravenous administration of (200mg/3weeks)
arm group label: Camrelizumab combined with Albumin Paclitacxel and Apatinib.
other name: SHR1210
other name: PD-1 inhibitor
intervention type: Drug
intervention name: Albumin Paclitacxel
description: intravenous administration of Albumin Paclitacxel (135mg/m2, d1, d8/3w, 4-6 cycles)
arm group label: Camrelizumab combined with Albumin Paclitacxel and Apatinib.
other name: Chemotherapy drug
intervention type: Drug
intervention name: Apatinib
description: Patients will be given oral of Apatinib (250mg Qd po for 5 days, take rest for 2 days every week)
arm group label: Camrelizumab combined with Albumin Paclitacxel and Apatinib.
other name: Anti-angiogenesis drug
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Hunan Cancer Hospital
investigator full name: Lin Wu
investigator title: Chief physician, director of department
mesh term: Adenocarcinoma
mesh term: Adenocarcinoma of Lung
mesh term: Apatinib
mesh term: Immune Checkpoint Inhibitors
sharing ipd: Yes
ipd description: De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
ipd info type: Study Protocol
ipd time frame: Data can be shared no earlier than 1 year following the date of publication
ipd access criteria: please contact the principal investigator of this study or correspondence author of published work.