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临床试验/NCT04629027
NCT04629027Unknown不适用

Establishment of a Comprehensive Evaluation System for the Efficacy of Immunologic Checkpoint Inhibitors in the Treatment of Advanced Non-small Cell Lung Cancer

Peking University Cancer Hospital & Institute1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年3月3日最近更新:
适应症
相关药物

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
1
主要终点
circulating tumor cell

研究概览

简要总结

Inhibitors of programmed cell death protein 1 (PD-1) and programmed cell death ligand 1 (PD-L1) are effective therapies for metastatic NSCLC lacking sensitizing EGFR or ALK mutations. First-line combination regimens that include a PD-1 or PD-L1 inhibitor may maximize the chance of response and lead to prolonged survival. PD-L1 expression is the only validated predictive biomarker for selecting pembrolizumab treatment. However, it is far from being the ideal biomarker and its role in predicting efficacy from ICPIs remains undefined due to conflicting results from randomized clinical trials. The selection of patients most likely to benefit from immunotherapy is crucial in order to avoid exposure to potentially toxic and ineffective drugs as well as to prevent inappropriate allocation of health resources. Further studies are clearly needed to better understand the mechanism of action of immunotherapy in vivo thus allowing the identification of other predictive biomarkers. Therefore, our research team intends to explore advanced non-small cell lung cancer treated with immune checkpoint inhibitors, by combining the evaluation criteria of solid tumor efficacy evaluation criteria (RECIST1.1), clinical pathological characteristics of patients, and dynamic monitoring of peripheral blood molecular biological markers, finding the correlation with the efficacy of immunotherapy, establish a detection mode for selecting patients with clinical benefits.

研究设计

研究类型
Observational
观察模型
Case Only
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

入选标准

  • Ages ≥18 years of age. Histologically confirmed stage IIIB-IV non-squamous non-small cell lung cancer. Life expectancy of at least 3 months.

排除标准

  • Previous treatment . Untreated CNS metastases. Active autoimmune disease. Surgery or significant traumatic injury. Active infection. History of allergy or hypersensitivity to immunotherapy components. Women are breastfeeding or pregnant. Requiring systemic treatment with either corticosteroids or other immunosuppressive medications.

结局指标

主要结局

circulating tumor cell

时间窗: 3 year

The selection of patients most likely to benefit from immunotherapy is crucial in order to avoid exposure to potentially toxic and ineffective drugs.

T cell marker

时间窗: 3 year

The selection of patients most likely to benefit from immunotherapy is crucial in order to avoid exposure to potentially toxic and ineffective drugs.

次要结局

未报告次要终点

研究者

发起方
Peking University Cancer Hospital & Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jian Fang

Principal Investigator

Peking University Cancer Hospital & Institute

研究点 (1)

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