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This study is an open, prospective and observational clinical trial. Adopting a prospective cohort study design, it selects patients with non-small cell lung cancer who receive neoadjuvant immunotherapy as the research subjects. Through systematic follow-up, it monitors the dynamic changes of cortisol levels of patients at different treatment stages and after surgery, and analyzes the associations between these changes and disease progression, treatment effect and adverse reactions.
This is a single-center prospective observational cohort study. No experimental intervention will be performed on the participants, all clinical treatments and examinations are fully in accordance with the routine clinical diagnosis and treatment specifications for resectable non-small cell lung cancer. We only prospectively collect the clinical data and laboratory test results of the participants to analyze the correlation between perioperative dynamic changes of cortisol and the outcomes of neoadjuvant immunochemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospective Observational Cohort of Resectable NSCLC Patients | This cohort includes patients with pathologically confirmed resectable stage ⅡA-ⅢB non-small cell lung cancer (NSCLC) who receive standard neoadjuvant PD-1/PD-L1 inhibitor combined with platinum-based doublet chemotherapy followed by radical surgery. This is a purely observational cohort: no study-specific intervention will be applied, all treatments and examinations are performed in full accordance with routine clinical practice. We will prospectively collect patients' clinical data, laboratory test results (including serum cortisol and ACTH levels) and pathological outcomes, to analyze the correlation between perioperative dynamic changes of cortisol and neoadjuvant treatment efficacy. |
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| Measure | Description | Time Frame |
|---|---|---|
| Major Pathological Response (MPR) Rate | Proportion of patients who achieved major pathological response, defined as viable residual tumor cells ≤10% in the resected primary tumor specimen after neoadjuvant immunochemotherapy, assessed according to IASLC standardized criteria. | Within 30 days after radical surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation Between Perioperative Cortisol Dynamic Changes and Pathological Response | The correlation between the relative change rate of serum cortisol (from baseline before neoadjuvant therapy to 1 day after surgery) and the proportion of residual viable tumor cells, as well as the achievement of MPR/pCR. | From baseline (within 7 days before neoadjuvant treatment initiation) to 7 days after radical surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Immune-Related Adverse Events (irAEs) | The cumulative incidence of all-grade and grade ≥3 irAEs during neoadjuvant treatment and 12 months after surgery, including endocrine toxicity, pulmonary toxicity, cutaneous toxicity, etc., graded according to CTCAE version 5.0. | From neoadjuvant treatment initiation to 12 months after surgery |
Inclusion Criteria:
Exclusion Criteria:
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This is a single-center prospective observational cohort study. The study population includes adult patients aged 18-75 years with histologically confirmed resectable stage ⅡA-ⅢB non-small cell lung cancer (NSCLC), who receive standard neoadjuvant PD-1/PD-L1 inhibitor combined with platinum-based chemotherapy followed by radical surgery in our center.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial People's Hospital, Guangzhou, Guangdong 510000 | Guangzhou | Guangdong | 510000 | China |
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Peripheral venous blood samples (for serum cortisol, ACTH, inflammatory biomarkers testing, and DNA extraction) and resected lung cancer pathological tissue (for MPR/pCR assessment and genomic testing)
| Incidence of Immune Checkpoint Inhibitor (ICIs)-Related Adrenocortical Dysfunction | The cumulative incidence of ICIs-related secondary adrenocortical dysfunction, including clinical and subclinical adrenocortical insufficiency, confirmed by serum cortisol and adrenocorticotropic hormone (ACTH) test results, assessed according to the Endocrine Society Clinical Practice Guidelines. | From neoadjuvant treatment initiation to 12 months after surgery |
| Disease-Free Survival (DFS) |
The time from radical surgery to the first occurrence of tumor recurrence, distant metastasis, or all-cause death, whichever comes first. |
| From radical surgery to 36 months after surgery |
| Overall Survival (OS) | The time from the initiation of neoadjuvant treatment to all-cause death. | From neoadjuvant treatment initiation to 36 months after treatment initiation |