跳至主要内容
临床试验/NCT05655663
NCT05655663招募中不适用

Evaluation of Vascular Toxicity of Immune Checkpoint Inhibitors (Nivolumab, Pembrolizumab, Atezolizumab) in Patients Head and Neck or Lung Cancer

Centre Henri Becquerel4 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年12月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
4
主要终点
Increasing of aortic arterial stiffness

研究概览

简要总结

Since the introduction of immune checkpoint ihibitors (ICIs) in cancer treatment, numerous studies have investigated different patient profiles to identify those who benefit from this class of drugs. Currently, hundreds of studies are being conducted with the aim of increasing the benefit of these therapies by combining ICIs with other treatments: immunomodulators, cytotoxics, targeted therapies, including cancer vaccines, which are peptides or RNA injected to trigger or increase a specific immune response against the tumor. Other approaches exist, such as oncology-specific "basket" studies, to focus on a genetic mutation independently of tumor location and determine whether a drug could treat the same genetic mutation found in several different locations. To date, ICIs are part of standard management in the US for patients with several diseases: advanced melanoma, NSCLC, Merkel cell carcinoma, head and neck squamous cell carcinoma, urothelial and renal cell carcinoma, cancers characterized by microsatellite instability, refractory Hodgkin's lymphoma, hepatocellular carcinoma, gastric cancer. In addition, trials are underway to investigate the benefit of ICIs in other locations.

Thus, taking into account the growing importance of ICIs in the oncological therapeutic strategy and the large number of patients treated, a better understanding of the vascular impact of these drugs is necessary.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

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

  • Signed informed consent.
  • Patient over 18 years of age
  • Patient with lung or head and neck cancer who should be treated with ICI as a single agent according to the market indications, decision taken during a multidisciplinary consultation meeting
  • WHO 0 or 1
  • Patient affiliated to or benefiting from a social protection scheme.

排除标准

  • Indication for combined anti-PD-1 and chemotherapy (for patients with lung cancer)
  • History of radiotherapy treatment
  • History of chemotherapy or targeted therapy within the last 3 weeks
  • Bilateral vascular carotid murmur
  • Absence of sinus rhythm
  • Presence of a pacemaker with permanent electrical stimulation
  • Absence of peripheral carotid and/or femoral pulses on both sides
  • Contraindication to the prescription of an ICI
  • Patient deprived of liberty by an administrative or judicial decision or patient placed under court protection, guardianship or curatorship
  • Pregnant or breastfeeding woman

结局指标

主要结局

Increasing of aortic arterial stiffness

时间窗: 42 days

Difference of aortic arterial stiffness between 42 days after inclusion and inclusion

次要结局

  • Overall survival(one year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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