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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06023797
Other study ID # ZS-chest
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2017
Est. completion date July 2023

Study information

Verified date September 2023
Source Shanghai Zhongshan Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 83
Est. completion date July 2023
Est. primary completion date November 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
China Zhencong Chen Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression-free survival (PFS) Progression-free defined as status of recurrence of lung cancer 2017-2023
Primary Overall survival (OS) Overall defined as the living status, alive or dead 2017-2023
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