Neoadjuvant Immunochemotherapy for Lung Cancer

NCT06023797 | Completed FDA Drug

• 1 other identifier: ZS-chest
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

neoadjuvant therapy

Outcome Measures

Primary Outcomes (2)

• Progression-free survival (PFS)

  Progression-free defined as status of recurrence of lung cancer

  2017-2023

• Overall survival (OS)

  Overall defined as the living status, alive or dead

  2017-2023

Study Arms (1)

MAICT

chemotherapy that included at one application of PD-1 inhibitor

Drug: Neoadjuvant immunochemotherapy

Interventions

Neoadjuvant immunochemotherapy DRUG

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

Also known as: surgery

MAICT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients who received NAICT and were operated at the Department of Thoracic Surgery, Zhongshan Hospital Fudan University between 2017 and 2022.

You may qualify if:

• Lung surgery was performed in the Department of Thoracic Surgery at Zhongshan Hospital;
• At least one cycle of neoadjuvant treatment containing the immune drug PD-1 immunosuppressant was performed before surgery;
• Malignancy was present and confirmed in the pathology before treatment and after surgery;
• The lung lesion was the primary lesion.

You may not qualify if:

• No lung surgery was performed until 2022.11;
• No preoperative neoadjuvant therapy was performed or recorded;
• Neoadjuvant therapy did not include immune drugs;
• Previous history of malignancy (including surgery and adjuvant therapy);
• Previous use of system-related immune medicines, such as immunosuppressants and monoclonal antibodies; and 6. Other conditions inappropriate for enrollment by the investigator.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhencong Chen

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: September 5, 2023
• Study Start: January 1, 2017
• Primary Completion: November 1, 2022
• Study Completion: July 1, 2023
• Last Updated: September 5, 2023

Record last verified: 2023-09

Locations

CN (1)