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

NCT06436040 | Recruiting

• 1 other identifier: 202311-10
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tumor Microenvironment; Lung Squamous Cell Carcinoma; Neoadjuvant Chemoimmunotherapy

Outcome Measures

Primary Outcomes (1)

• Pathological response assessment

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

  through study completion, an average of 2 year

Study Arms (2)

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

Other: Pathological response assessment

non-MPR

defned as having more than 10% residual viable tumor cells by routine hematoxylin and eosin (H\&E) staining after therapy

Other: Pathological response assessment

Interventions

Pathological response assessment OTHER

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

MPR(major pathological response); non-MPR

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• aged 40 to 80 years;
• had histologically confirmed LUSC with operable locally advanced stage
• no prior anti-tumor therapy; received neoadjuvant immunotherapy consisting of three cycles of anti-PD-1 ICB plus nab-paclitaxel and carboplatin
• pre-treatment tissues

You may not qualify if:

• the presence of central nervous system metastases
• the presence of immunodeficiency disease; previous therapies with immunosuppressants within 14 days prior to the initiation of study treatment;
• uncontrolled hypertension
• history of or having pulmonary fibrosis or interstitial lung disease

Sponsors & Collaborators

• Tang-Du Hospital: lead

Study Sites (1)

Hongtao Duan

Xi’an, Shanxi, 710038, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

pre-treatment and post-treatment tumors from patients with operable locally advanced lung squamous cell carcinoma

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: May 30, 2024
• Study Start: January 24, 2024
• Primary Completion: November 16, 2024
• Study Completion: May 16, 2025
• Last Updated: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)