Circulating Tumor DNA (ctDNA) Dynamic Monitoring Plus Artificial Intelligence (AI)-Based Pathology Predict the Efficacy of Chemoimmunotherapy in Resectable Lung Squamous Cell Carcinoma (LSCC)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Development of computer algorithm to identify pCR features
研究概览
简要总结
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.
详细描述
This study is a single-center, observational, non-interventional, prospective study. 50 patients diagnosed with lung squamous cell carcinoma receiving neoadjuvant chemoimmunotherapy (ranging 2 to 4 cycles) will be planned to be enrolled in the study. Pre-treatment biopsy tissues of enrolled patients will be collected for whole exon sequencing (WES) testing, and personalized detection panel will be customized based on WES testing results. Peripheral blood will be collected 1 day before each cycle of neoadjuvant therapy, 1 day before surgery, 3 days after surgery, and 3 weeks after surgery for ctDNA testing. In addition, the prediction model of AI-based pathology will be constructed by AI deep learning based on pathological sections of pre-treatment biopsy tissues. All inclued patients will be regularly followed up for at least 5 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •According to the American Joint Committee on Cancer (AJCC) eighth edition of the Lung Cancer Staging Manual, the clinical stage is stage II-IIIb resectable or potentially resectable tumor
- •Sufficient tissue/blood samples are available to meet research requirements
- •The ECOG PS score is 0-1
排除标准
- •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
- •Previous use of CTLA-4, PD-1, or PD-L1 immune checkpoint inhibitors
- •Patients with interstitial lung disease
- •Patients with acute or chronic infectious disease
- •Pregnant and lactating women
- •Patients who have undergone other clinical drug trials
结局指标
主要结局
Development of computer algorithm to identify pCR features
时间窗: From retrospective data collection to algorithm development (6 month)
Development of computer algorithm to identify pCR features
ctDNA resolution
时间窗: Up to 2 years
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)
Pathologic completet response (pCR) rate
时间窗: Up to 1 year
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.
Validation of computer algorithm to identify pCR features
时间窗: From prospective data collection to algorithm validation (6 months)
Validation of computer algorithm to identify pCR features
次要结局
- Major pathological response (MPR) rate(Up to 1 year)
- Perioperative pain evaluation(Up to 3 years)
- Health-related Quality of Life(Up to 5 years)
- Objective response rate(ORR)(Up to 1 year)
- Adverse events (AEs)(Up to 5 years)
- Perioperative complications rate(Up to 3 years)
- Disease free survival (DFS)(Up to 5 years)
- Overall survival (OS)(Up to 5 years)
研究者
Liu Wenliang
Professor
Second Xiangya Hospital of Central South University