Mechanism Study to Investigate Difference in Efficacy of Neoadjuvant Chemoimmunotherapy in Lung Squamous Cell Carcinoma
NCT ID: NCT06436040
Last Updated: 2024-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
40 participants
OBSERVATIONAL
2024-01-24
2025-05-16
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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MPR(major pathological response)
defned as having no more than 10% residual viable tumor cells by routine hematoxylin and eosin (H\&E) staining after therapy
Pathological response assessment
The pathological response classification in our study was based on the histopathologic examination of the surgically resected specimens reviewed by two experienced pathologists.
non-MPR
defned as having more than 10% residual viable tumor cells by routine hematoxylin and eosin (H\&E) staining after therapy
Pathological response assessment
The pathological response classification in our study was based on the histopathologic examination of the surgically resected specimens reviewed by two experienced pathologists.
Interventions
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Pathological response assessment
The pathological response classification in our study was based on the histopathologic examination of the surgically resected specimens reviewed by two experienced pathologists.
Eligibility Criteria
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Inclusion Criteria
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
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
40 Years
80 Years
ALL
No
Sponsors
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Tang-Du Hospital
OTHER
Responsible Party
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Locations
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Hongtao Duan
Xi’an, Shanxi, China
Countries
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Facility Contacts
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Other Identifiers
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202311-10
Identifier Type: -
Identifier Source: org_study_id
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