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临床试验/NCT04656119
NCT04656119招募中不适用

Discovery of Biomarkers Related to the Efficacy and Adverse Reactions of Immune Checkpoint Inhibitors Based on Metabolism-genomics

Beijing Chao Yang Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年11月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
immune-related adverse events incidence

研究概览

简要总结

Immune checkpoint inhibitors (ICIs) are an important breakthrough in cancer therapy and have been increasingly used.However, ICIs can cause a unique spectrum of side effects termed immune-related adverse events (irAEs),which can affect any organ systems and in some cases are fulminant or even fatal.In clinical practice, irAEs and clinical efficacy maybe various for patients with same standard treatment, and some studies have shown that gene and metabolic differences in cancer patients may be an important factor. In this project, peripheral blood samples from cancer patients will be collected prospectively at baseline, and at regular intervals (2 cycles, about 6 weeks) for about 30 weeks, then these blood samples will be analyzed using the technique of genomics, metabonomics.

The investigators aim to find biomarkers associated with irAE or clinical efficacy. When the sample size and data is big enough, the investigators plan to establish a prediction model using machine learning to access the safety and efficacy of ICIs for cancer patients. Our study have important clinical implications in the prediction and early management of severe, potentially life-threatening immune-related toxicity.

研究设计

研究类型
Observational
观察模型
Case Control
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

入选标准

  • Histologically confirmed malignant tumor, no relative contraindications for immunotherapy, in line with the standards of immunotherapy
  • Receive immune checkpoint inhibitors (ICIs) for the first time or have received ICIs but no immune-related adverse reactions have occurred
  • Have provided informed consent, are willing to participate in study and routine follow-up
  • At least one measurable lesion according to Guidelines for response criteria for use in trials testing immunotherapeutics (iRECIST)

排除标准

  • Active, known, suspected or a documented history of autoimmune disease
  • Eastern Cooperative Oncology Group(ECOG) performance status 3-4
  • Long-term hormone therapy,corticosteroids (>10mg/day prednisone curative dose)
  • Subjects with human immunodeficiency virus (HIV)
  • Subjects with other tumors
  • Myocardial infarction, poorly control led arrhythmia, New York Heart Association (NYHA) standard III-IV cardiac insufficiency or left ventricular ejection fraction (LVEF)<50% in the last 6 month
  • Active tuberculosis
  • Active or a documented history of interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severely impaired lung function
  • Common Terminology Criteria for Adverse Events (CTCAE) peripheral neuropathy grade≥2
  • History of alcohol abuse

结局指标

主要结局

immune-related adverse events incidence

时间窗: November,2020-November,2025

次要结局

  • Complete response (CR)(November,2020-November,2025)
  • Stable disease (SD)(November,2020-November,2025)
  • Progressive disease (PD)(November,2020-November,2025)
  • Partial response (PR)(November,2020-November,2025)

研究者

发起方
Beijing Chao Yang Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lihong Liu

Director of Pharmacy department

Beijing Chao Yang Hospital

研究点 (1)

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