Mechanism Study to Investigate Difference in Efficacy of Neoadjuvant Chemoimmunotherapy in Lung Squamous Cell Carcinoma

Tang-Du Hospital40 enrolled

Overview

To explore mechanisms of immunotherapy resistance and relation to changes in the TME before and after PD-1 blockade combined with chemotherapy

The biobank of thoracic surgery department of Tangdu Hospital collected pre-treatment tissues from patients during endoscopy. The investigators retrospectively summarized the clinical characteristics of these patients and patients with operable locally advanced lung squamous cell carcinoma were selected and followed. The investigators plan to employ snRNA-seq and scRNA-seq respectively to profile 20 samples of paired pre-treatment and post-treatment tumors from ten patients (discovery cohort) to create a cell atlas for analysis, and spatial transcriptomics to examine 8 samples from four patients. In discovery cohort, estimated 5 patients achieve major pathological response (MPR) and 5 patients achieve non-MPR after NICB. After analyzing the results of discovery cohort, the investigators will collect frozen tissues and formalin-fixed, paraffin-embedded (FFPE) tissue from our biobank for bulk RNA-seq analysis or immunohistochemistry (IHC) staining as validation cohort to further investigate the predictive value and biological significance of our markers.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Tumor Microenvironment Lung Squamous Cell Carcinoma Neoadjuvant Chemoimmunotherapy

Interventions

Pathological response assessmentOTHER

The pathological response classification in our study was based on the histopathologic examination of the surgically resected specimens reviewed by two experienced pathologists.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. aged 40 to 80 years; 2. had histologically confirmed LUSC with operable locally advanced stage 3. no prior anti-tumor therapy; received neoadjuvant immunotherapy consisting of three cycles of anti-PD-1 ICB plus nab-paclitaxel and carboplatin 4. pre-treatment tissues Exclusion Criteria: 1. the presence of central nervous system metastases 2. the presence of immunodeficiency disease; previous therapies with immunosuppressants within 14 days prior to the initiation of study treatment; 3. uncontrolled hypertension 4. history of or having pulmonary fibrosis or interstitial lung disease

Locations (1)

Hongtao Duan

Xi’an, Shanxi, China

RECRUITING

Outcomes

Primary Outcomes

Pathological response assessment

MPR: Resected tumors with ≤10% viable tumor cells were considered to have a MPR

Time frame: through study completion, an average of 2 year

Data from ClinicalTrials.gov

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