Neoadjuvant Immunochemotherapy for Lung Cancer

Retrospective Research on Lung Cancer Patients Receiving Neoadjuvant Immunochemotherapy From Zhongshan Hospital Fudan University.

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Drug: Neoadjuvant immunochemotherapy

• Study Type: Observational
• Enrollment (Actual): 83

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Zhencong Chen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): November 1, 2022
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: August 28, 2023
• First Submitted That Met QC Criteria: September 1, 2023
• First Posted (Actual): September 5, 2023

Study Record Updates

• Last Update Posted (Actual): September 5, 2023
• Last Update Submitted That Met QC Criteria: September 1, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: neoadjuvant therapy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: ZS-chest

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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