Clinical trial NCT06436040: Mechanism Study to Investigate Difference in Efficacy of Neoadjuvant Chemoimmunotherapy in Lung Squamous Cell Carcinoma
Official title: A Mechanism Study to Investigate the Difference in Efficacy of Neoadjuvant PD-1 Blockade Combined With Chemotherapy in the Treatment of IIA-IIIB Stage Lung Squamous Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tumor Microenvironment
Lung Squamous Cell Carcinoma
Neoadjuvant Chemoimmunotherapy
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
First posted: 2024-05-30
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients enrolled in this study had histologically confirmed LUSC with operable locally advanced stage, no prior anti-tumor therapy, and received neoadjuvant immunotherapy consisting of three cycles of anti-PD-1 ICB plus nab-paclitaxel and carboplatin

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pathological response assessment
timeFrame: through study completion, an average of 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Hongtao Duan
state: Shanxi
Study officials:
References: