Construction of a Perioperative Comprehensive Diagnosis and Treatment System for Lung Cancer in the Era of Neoadjuvant Immunotherapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 350
- 主要终点
- Pathological Complete Response (pCR)
研究概览
简要总结
The goal of this study is to develop and refine an integrated minimally invasive care pathway for resectable lung cancer in the immunotherapy era, establishing a novel precision perioperative immunotherapy paradigm encompassing original techniques and clinical applications.
详细描述
Lung cancer remains the leading cause of cancer-related mortality in China and globally, imposing a substantial disease burden on society. Although comprehensive treatment strategies centered on surgery have improved patient outcomes, and perioperative immunotherapy-particularly immune checkpoint inhibitors-has profoundly reshaped the therapeutic landscape, significant knowledge gaps and critical challenges persist in this field. These challenges include uncertain beneficiary populations, poorly understood immune mechanisms, inaccurate efficacy prediction, difficult determination of resection margins, controversial efficacy assessment, and lack of effective early warning for adverse reactions.
This study will systematically identify biomarkers for early diagnosis and recurrence monitoring through multi-omic analysis of peripheral blood immune cell subsets and non-invasive liquid biopsies; investigate the tumor immune microenvironment's role in immunotherapy response mechanisms and predict treatment efficacy via multi-omic studies of tissue specimens; develop novel AI- and radiomics-assisted pathological assessment systems and prognostic prediction models; implement perioperative symptom assessment for timely identification of immune-related adverse events (irAEs) while conducting prehabilitation training for perioperative nursing care.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old;
- •NSCLC patients underwent radical surgical resection;
- •Adequate clinical-pathologic data, imaging data and follow-up data obtainable for multi-omics analysis;
- •Scheduled for or currently receiving neoadjuvant/perioperative immunotherapy.
排除标准
- •Histology of other malignant tumors, including concurrent malignant tumors of other organ systems;
- •Unresectable advanced disease (Stage IV) or locally advanced unresectable (Stage IIIC);
- •Pregnancy or lactation;
- •Insufficient sample quality;
- •Severe organ dysfunction (e.g. cardiac or renal insufficiency);
- •Other judgments by the Investigator that the patient should not participate in the study.
结局指标
主要结局
Pathological Complete Response (pCR)
时间窗: At surgery (typically 3-6 months post-treatment initiation)
Pathologic Complete Response (pCR) is defined as the absence of residual tumor in both the primary lung tumor site and all sampled regional lymph nodes after neoadjuvant immunotherapy, confirmed through systematic pathological examination of the surgical specimen.
次要结局
- Major Pathological Response (MPR)(At surgery (typically 3-6 months post-treatment initiation))
- Symptom Severity Score(Preoperative (T1: 2-4 weeks pre-surgery), postoperative (e.g., T3: 12-24 hours post-surgery, T5: 30 days post-surgery), and up to 90 days post-surgery.)
- Objective Response Rate (ORR)(After two cycles or four cycles of neoadjuvant therapy (each cycle is 21 days).)
- Recurrence-free Survival (RFS)(Through study completion, an average of 2 years)
- Overall Survival (OS)(Through study completion, an average of 2 years)
- Immune-Related Adverse Event (irAE) Incidence(Periprocedural and up to 6 months post-treatment.)
- MRD (minimal residual disease) dynamics after neoadjuvant immunotherapy(Periprocedural and every three to six months post-treatment (up to three years))
- Changes in PD-L1 expression (TPS) and TIL subpopulations (CD8+/FOXP3+ ratios, et al) before and after neoadjuvant immunotherapy(Periprocedural.)
研究者
Yang Fan, MD
Vice President
Peking University People's Hospital