The goal of this observational study is to explore whether ctDNA dynamic monitoring plus AI-based pathology can more effectively predict the therapeutic effect of neoadjuvant chemoimmunotherapy for resectable lung squamous cell carcinoma, so as to accurately guide clinical diagnosis and treatment.
Histopathology or cytology confirmed the lung squamous cell carcinoma
Age ranging from 18 to 75
Agree to participate in this study and sign an informed consent form
Treatment-naive tumor
Patients who cannot understand the content of the experiment and cannot cooperate, and those who refuse to sign the informed consent form
Non-squamous NSCLC
Unresectable IIIa-IIIb tumor
Patients with solid organ or blood system transplantation
Resectable or potentially resectable stage II-IIIb lung squamous cell carcinoma patients receiving neoadjuvant chemoimmunotherapy
Cohort
Prospective
WES and ctDNA detection
Diagnostic testWES and ctDNA detection
Pathologic completet response (pCR) rate
pCR rate is defined as the percentage of participants having an absence of residual tumor cells in resected lung specimens and lymph nodes following completion of neoadjuvant therapy.
ctDNA resolution
ctDNA resolution is defined as the change or resolution in tumor-derived DNA found in the bloodstream from diagnosis to after neoadjuvant therapy and after surgery, correlated with pathologic complete response (pCR)
Development of computer algorithm to identify pCR features
Development of computer algorithm to identify pCR features
Validation of computer algorithm to identify pCR features
Validation of computer algorithm to identify pCR features
Major pathological response (MPR) rate
MPR rate is defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and resected lymph nodes following completion of neoadjuvant therapy.
Objective response rate(ORR)
The proportion of patients achieved complete or patial remission(Imageological) according to RECIST 1.1 prior to definitive surgery.
Adverse events (AEs)
Number of participants experiencing AEs will be recorded. An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Perioperative complications rate
Number of participants experiencing perioperative complications will be recorded.
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Second Xiangya Hospital of Central South University
Lead sponsor
Shanghai OrigiMed Co., Ltd.
Collaborator
