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Neoadjuvant Immunochemotherapy for Lung Cancer

Sponsor
Shanghai Zhongshan Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT06023797
Collaborator
(none)
83
Enrollment
1
Location
77.9
Actual Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

We retrospectively analyzed lung cancer patients who had NAICT and surgery in the Department of Thoracic Surgery, Zhongshan Hospital. NAICT was defined as chemotherapy that included at one application of PD-1 inhibitor.

Condition or Disease Intervention/Treatment Phase
  • Drug: Neoadjuvant immunochemotherapy

Study Design

Study Type:
Observational
Actual Enrollment :
83 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Retrospective Research on Lung Cancer Patients Receiving Neoadjuvant Immunochemotherapy From Zhongshan Hospital Fudan University.
Actual Study Start Date :
Jan 1, 2017
Actual Primary Completion Date :
Nov 1, 2022
Actual Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
MAICT

chemotherapy that included at one application of PD-1 inhibitor

Drug: Neoadjuvant immunochemotherapy
Patients who received NAICT and were operated at the Department of Thoracic Surgery, Zhongshan Hospital Fudan University between 2017 and 2022.
Other Names:
  • surgery

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Progression-free survival (PFS) [2017-2023]

      Progression-free defined as status of recurrence of lung cancer

    2. Overall survival (OS) [2017-2023]

      Overall defined as the living status, alive or dead

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Lung surgery was performed in the Department of Thoracic Surgery at Zhongshan Hospital;

    2. At least one cycle of neoadjuvant treatment containing the immune drug PD-1 immunosuppressant was performed before surgery;

    3. Malignancy was present and confirmed in the pathology before treatment and after surgery;

    4. The lung lesion was the primary lesion.

    Exclusion Criteria:

    1. No lung surgery was performed until 2022.11;

    2. No preoperative neoadjuvant therapy was performed or recorded;

    3. Neoadjuvant therapy did not include immune drugs;

    4. Previous history of malignancy (including surgery and adjuvant therapy);

    5. Previous use of system-related immune medicines, such as immunosuppressants and monoclonal antibodies; and 6. Other conditions inappropriate for enrollment by the investigator.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zhencong Chen Shanghai Shanghai China 200032

    Sponsors and Collaborators

    • Shanghai Zhongshan Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shanghai Zhongshan Hospital
    ClinicalTrials.gov Identifier:
    NCT06023797
    Other Study ID Numbers:
    • ZS-chest
    First Posted:
    Sep 5, 2023
    Last Update Posted:
    Sep 5, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Shanghai Zhongshan Hospital
    neoadjuvant therapy
    Additional relevant MeSH terms:
    Lung Neoplasms

    Study Results

    No Results Posted as of Sep 5, 2023