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临床试验/ACTRN12621000171819
ACTRN12621000171819招募中1 期

IMaging of cancer imMUNOtherapy targets with Positron Emission Tomography: Characterising PD-L1 with 89Zr- Durvalumab (MEDI4736)

Peter MacCallum Cancer Centre0 个研究点目标入组 5 人开始时间: 2021年2月18日最近更新:
适应症

试验速览

阶段
1 期
状态
招募中
发起方
入组人数
5

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Non-randomised trial
主要目的
Treatment
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 o limit(—)
性别
All

入选标准

  • 1. Written informed consent provided.
  • 2. Female or male
  • 3. Life expectancy greater than or equal to 12 weeks
  • 4. Minimum age greater than or equal to 18 years, no maximum age.
  • 5. Body weight >30kg
  • 6.Patients with NSCLC and with advanced incurable disease, and with metastatic disease apparent on FDG-PET
  • 7. Histopathology with PD-L1 positive tumour cells >25%. Although, in the metastatic setting >50% is the accepted cut-off, the threshold for Stage III patients remains poorly defined. A cut-off of >25% to broaden the eligibility criteria for enrolment is considered appropriate in this study
  • 8. Subjects with an estimated glomerular filtration rate (eGFR) > 50ml/min as measured using the MDRD formula (Modification of Diet in Renal Disease).
  • 9. Eastern Cooperative Group Oncology Group (ECOG) performance score of 0-2.

排除标准

  • 1.Pregnant or breastfeeding females
  • 2.Known sensitivity or allergy to anti-PD-L1 agents
  • 3.Any serious medical condition which the investigator feels may interfere with the procedures or evaluations of the study
  • 4.Patients unwilling or unable to comply with protocol or with a history of non-compliance or inability to grant informed consent

研究者

发起方
Peter MacCallum Cancer Centre

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