CTIS2023-509486-20-00进行中(未招募)1 期
Assessment of PET Tracers to Evaluate T Cell Change and Activation in Relation to Immunotherapy Treatment Response in Non-Small Cell Lung Cancer (iRelate) - 2023-509486-20-00
Amsterdam UMC0 个研究点目标入组 34 人开始时间: 2024年2月28日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 34
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+(—)
- 性别
- All
入选标准
- •To be eligible to participate in this study, a patient must meet all of the following criteria: 1. Histologically confirmed NSCLC 2. T1-4N0-2, lesion size of =2cm, at time of the restaging FDG PET/CT 3. Planned to undergo resection after chemo-IO according to routine treatment guidelines 4. Willing and able to provide written informed consent for the trial 5. Above 18 years of age on day of signing informed consent 6. Have measurable disease based on RECIST 1.15 7. Have a ECOG performance status of 0-1, and are considered operable based on pulmonary function test and/or exercise testing
排除标准
- •A patient who meets any of the following criteria will be excluded from participation in this study: 1. Patients deemed inoperable 2. Patients with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of day 0. Inhaled or topical steroids, and adrenal replacement steroid >10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease. 3. Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 4. Patient is pregnant or breastfeeding or expecting to conceive within the projected duration of the trial.
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