The Multimodal Model Predicts the Efficacy of Immunotherapy Checkpoint Inhibitors Combined With Chemotherapy for the Treatment of Advanced Non-small Cell Lung Cancer and the Occurrence Risk of Chemotherapy-induced Pneumonitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
Immunotherapy is a crucial first-line treatment for advanced non-small cell lung cancer (NSCLC) without gene mutations. However, chemotherapy-induced pneumonitis (CIP) is a common adverse effect of immunotherapy, with severe cases even posing a threat to life. Therefore, identifying effective biomarkers and models for predicting the efficacy of immunotherapy in NSCLC is of great significance. At present, there is still a lack of effective predictive indicators in clinical practice. This study aims to construct a multimodal model based on factors such as chest CT, pulmonary function, cellular immunity, and cytokine levels to accurately predict the efficacy of combined therapy and the occurrence of related adverse reactions in NSCLC, in order to provide a reference for individualized treatment.
详细描述
This is an observational cross-sectional retrospective study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •Consistent with the "Chinese Medical Association Guidelines for the Diagnosis and Treatment of Lung Cancer (2018 Edition)," histologically confirmed as NSCLC;
- •According to the 8th edition of the AJCC TNM staging system, it is stage III B to IV and not suitable for surgery;
- •Age ≥18 years;
- •First-time recipients of immunotherapy combined with chemotherapy;
- •Baseline data within 1 month before the start of treatment is complete (at least including chest CT, pulmonary function, and laboratory tests);
- •At least 1 measurable lesion according to RECIST 1.1;
- •Receiving immune checkpoint inhibitor therapy for more than 2 cycles;
- •Clinical data is complete.
排除标准
- •Presence of other malignant tumors;
- •Previous exposure to immunotherapy or systemic chemotherapy;
- •Patients with severe dysfunction of vital organs (heart, liver, lungs, kidneys) and bone marrow at baseline;
- •Presence of severe infectious diseases, active autoimmune diseases, or immune deficiencies that significantly affect immune function;
- •Organ transplantation;
- •Pregnant or lactating women;
- •Incomplete clinical treatment or follow-up information.
结局指标
主要结局
Progression-free survival (PFS)
时间窗: From first dose through 31 August 2025, corresponding to a maximum follow-up of approximately 5.5 years (~290 weeks).
Time from the first dose of immune-checkpoint inhibitor plus chemotherapy to the earliest date of radiologic progression (per RECIST 1.1) or death from any cause.
次要结局
- The disease control rate (DCR)(Tumor response assessed every 6 weeks (±1 week) for up to 24 weeks or until progression/death/cut-off (31 Aug 2025); the proportion will be calculated from the best response recorded within the first 24 weeks (4 cycles) per RECIST 1.1.)
- Checkpoint inhibitor pneumonitis (CIP)(Within 4 months after the initiation of immunotherapy combined with chemotherapy.)