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

Recruiting

• Conditions: Lung Squamous Cell Carcinoma; Tumor Microenvironment; Neoadjuvant Chemoimmunotherapy
• Interventions: Other: Pathological response assessment

• Registration Number: NCT06436040
• Lead Sponsor: Tang-Du Hospital

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.

Study Timeline

• Study First Submitted: 2024-01-22
• Study Start: 2024-01-24
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-28
• Last Update Submitted: 2024-05-28
• Study First Posted: 2024-05-30
• Last Update Posted: 2024-05-30
• Primary Completion: 2024-11-16
• Study Completion: 2025-05-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MPR(major pathological response)	Pathological response assessment	defned as having no more than 10% residual viable tumor cells by routine hematoxylin and eosin (H\&E) staining after therapy
non-MPR	Pathological response assessment	defned as having more than 10% residual viable tumor cells by routine hematoxylin and eosin (H\&E) staining after therapy

Primary Outcome Measures

Name	Time	Method
Pathological response assessment	through study completion, an average of 2 year	MPR: Resected tumors with ≤10% viable tumor cells were considered to have a MPR

Trial Locations

Locations (1)

Hongtao Duan; 🇨🇳 Xi'an, Shanxi, China