Risk Factors of Immune-ChEckpoint Inhibitors MEdiated Liver, Gastrointestinal, Endocrine and Skin Toxicity
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Differentially expressed genes in circulating immune cells between patients with and without irAEs.
研究概览
简要总结
"Risk factors of Immune-ChEckpoint inhibitor MEdiated Liver, gastrointestinal, endocrine and skin Toxicity" (ICEMELT) study is a prospective multicenter cohort study, enrolling patients who are scheduled to receive (1) single agent PD1/L1 inhibitor; (2) PD1/L1 inhibitor plus CTLA4 inhibitor; (3) platinum-based chemotherapy + PD1/L1 inhibitor; (4) PD1/L1 inhibitor and tyrosine kinase inhibitor and (5) PD1/L1 inhibitor and vascular endothelial growth factor (VEGF) inhibitor.
详细描述
This project is based on strong multidisciplinary collaboration between oncologists, gastroenterologists/hepatologists, immunologists and basic scientists affiliated with (1) Western Sydney University, (2) University of Sydney, (3) Western Sydney Local Health District (4) New South Wales Health Pathology, (5) Westmead Institute for Medical Research.
Recruitment sites:
- Blacktown Mt Druitt Hospital.
- Westmead Hospital.
Research samples collection, processing and storage:
- Blacktown Clinical School, Western Sydney University.
- Westmead Institute for Medical Research, the University of Sydney.
- New South Wales Health Pathology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to comprehend the requirements and procedures for the study and to provide informed consent before entering the study
- •Solid malignant tumour (stage III-IV)
- •Treated with ICI-based therapeutic regimens
排除标准
- •Inability to give written informed consent
- •Patients with a cognitive impairment, an intellectual disability or a mental condition that will interfere with the patient's ability to understand the requirements of the study
结局指标
主要结局
Differentially expressed genes in circulating immune cells between patients with and without irAEs.
时间窗: Week 0-48
This objective will be achieved through single-cell sequencing.
Expression of TIM-3, LAG3, VISTA and other inhibitory checkpoint molecules on tumour-infiltrating T cells.
时间窗: Week 0-48
In order to ascertain this result, our objective is to utilize spatial transcriptomics and mass spectrometry.
次要结局
- Association of pre-treatment BMI, neutrophil-to-lymphocyte ratio and other clinical parameters with irAEs.(Week 0-48)
研究者
Golo Ahlenstiel
Professor of Medicine
Western Sydney Local Health District