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Change in NLR and Survival Among Advanced Lung Cancer Patients Receiving ICIs With Immunomodulator

Sponsor
Chung Shan Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT04352335
Collaborator
(none)
53
Enrollment
1
Location
2.6
Actual Duration (Months)
20.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main objective of this study is to evaluate the change of neutrophil to lymphocyte ratio (NLR) after 6-week treatment of immune checkpoint inhibitors (ICIs) with or without immunomodulatory drugs and recognize the effect of post-treatment NLR and overall survival in advanced lung cancer patients by retrospective review.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    In recent years, the therapeutic strategies for lung cancer have been enriched with small molecular targeted therapy and immunotherapy. In this retrospective study, we will observe the change in NLR and explore its possible association with survival among advanced lung cancer patients receiving Immune checkpoint inhibitors (ICIs) with and without such immuno-modulator, Astragalus Polysaccharide Injection. It can be used to understand the relationship between NLR values and the survival rate of lung cancer patients after ICIs treatment. Physicians can refer to this result to give patients the suitable treatment recommendations.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    53 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Change in Neutrophil to Lymphocyte Ratio (NLR) and Survival Among Advanced Lung Cancer Patients Receiving Immune Checkpoint Inhibitors With Immunomodulator: a Retrospective Study
    Actual Study Start Date :
    Apr 14, 2020
    Actual Primary Completion Date :
    Jul 1, 2020
    Actual Study Completion Date :
    Jul 1, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    Cohort 1：ICI treatment with immunomodulator

    Lung cancer patients received immunological checkpoint inhibitors (ICIs) and any immunomodulatory drugs.
    Cohort 2：ICI treatment without immunomodulator

    Lung cancer patients received immunological checkpoint inhibitors (ICIs).

    Outcome Measures

    Primary Outcome Measures

    1. Neutrophil to lymphocyte ratio (NLR) [Baseline, 4~8 week]

    Secondary Outcome Measures

    1. Overall Survival (OS) [4 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion Criteria

    • Aged 20 years and older.

    • Patients who have been given a diagnosis of lung cancer.

    • Previously advanced lung cancer patients first treated with ICIs from Oct 1, 2015 to Oct 31, 2019.

    Exclusion Criteria

    • Patients who have no hematological laboratory data available at baseline (within 3 days prior to ICI treatment) and the 6th week (± 2 weeks) after ICI treatment initiation.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chung Shan Medical University Hospital Taichung Taiwan

    Sponsors and Collaborators

    • Chung Shan Medical University

    Investigators

    • Principal Investigator: Shih-Ming TSAI, M.D., Ph.D., Chung Shan Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    LJ Hwu, Attending physician, Chung Shan Medical University
    ClinicalTrials.gov Identifier:
    NCT04352335
    Other Study ID Numbers:
    • CSMUH02-NLR
    First Posted:
    Apr 20, 2020
    Last Update Posted:
    Jul 2, 2020
    Last Verified:
    Jun 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by LJ Hwu, Attending physician, Chung Shan Medical University
    neutrophil to lymphocyte ratio (NLR)
    immunomodulator
    Additional relevant MeSH terms:
    Lung Neoplasms

    Study Results

    No Results Posted as of Jul 2, 2020