Construction of a Efficacy Stratification Prognostic and Prediction Model for Perioperative Immunotherapy in Non - Small Cell Lung Cancer Based on Multi - Omics Biomarkers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 主要终点
- Pathological response after immune neoadjuvant therapy
研究概览
简要总结
This research focuses on exploring biomarkers for the application of PD - 1/PD - L1 immune checkpoint inhibitors in the perioperative immunotherapy of lung cancer. Multi - index tests are conducted on tissues prior to treatment, as well as blood samples at baseline and during the treatment course. The goal is to identify biomarkers capable of predicting the efficacy of neoadjuvant and adjuvant immunotherapies. Additionally, by integrating these multiple - index data into models, patients are to be stratified based on their potential benefits from perioperative immunotherapy, providing personalized guidance for clinical decision - making.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NSCLC, clinical tumor stage II-IIIB
- •Without EGFR/ALK gene mutation
- •Patient 18 years or older.
- •Scheduled for neoadjuvant immunotherapy.
- •Eastern Cooperative Oncology Group (ECOG) performance status score 0-1
- •Life expectancy ≥ 12 weeks.
- •Patient able to understand and sign written informed consent.
排除标准
- •With other cancers (excluding NSCLC or skin cancer other than melanoma, or cancers treated curatively with follow up of more than 5 years without recurrence).
- •With history of chemotherapy or radiotherapy (including pre - operative and post - operative adjuvant chemotherapy and radiotherapy) or systemic anti - tumor treatment.
- •with autoimmune diseases unsuitable for PD - 1 monoclonal antibody treatment, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Guillain - Barré syndrome, or multiple sclerosis.
- •Patients who are unlikely to comply with the protocol (e.g. uncooperative attitude), inability to return for subsequent visits) and/or otherwise considered by the Investigator to be unlikely to complete the study.
结局指标
主要结局
Pathological response after immune neoadjuvant therapy
时间窗: From enrollment to surgery at 18 weeks
The primary evaluation indicators are pathological complete response (pCR) and major pathological response (MPR). MPR refers to the residual tumor cells in the surgically resected specimens being ≤ 10%, while pCR requires the complete disappearance of tumor cells.
次要结局
- 2-year Progression-Free Survival(PFS1)(PFS of patients from the time of enrollment until two years)
- 2-year Progression-Free Survival(PFS2)(PFS from the start of adjuvant immunotherapy to 2 years.)
研究者
Ziming Li
Chief of the Oncology Department
Shanghai Chest Hospital