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临床试验/NCT06959433
NCT06959433尚未招募3 期

Safety and Efficacy of Lu-177 PSMA Treatment in Metastatic Clear Cell Renal Carcinoma

Ankara University0 个研究点目标入组 20 人开始时间: 2025年8月1日最近更新:
干预措施

试验速览

阶段
3 期
状态
尚未招募
入组人数
20
主要终点
toxicity analysis

研究概览

简要总结

Summary Renal Cell Carcinoma (RCC) consists of 2% of all malignencies. RCCs are generally divided to histopathological subtypes as clear cell and non-clear cell variants. Clear cell variant responsible for the 75-80% of all RCCs. It is reported that 20-30% of RCCs are metastatic at the diagnosis and 5 years survival is approximately is 10-20% in this group of patients. Moreover, 60% of patients who are not metastatic at the diagnosis, develop metastates within 2-3 years. 2nd and 3th line effective treatment option in metastatic RCCs patients has been a subject of interest.

PSMA (protatate specific membrane antigen) with the other name glutamate carboxypeptidase, is a transmembrane protein and overexpresses in prostate adenocarcinomas and neoangiogenesis spots of endothelium of other several tumor types. It infronts as a target for theranostic consept for mainly prostate cancer in nuclear medicine. As a radionuclide treatment option, Lu-177 PSMA treatment is proved as safe and effective treatment option in castration resistant prostata cancer patients. After its widely use in prostate cancer, it is reported that PSMA molecule can be used for imaging of RCC patients and PSMA uptake is higher than 18F-FDG. For this reason, Lu-177 PSMA treatment can be a systemic treatment option in RCC patients who have progress afer 1st cycle treatment. In this study we aimed to safety and efficacy of Lu-177 PSMA treatment in metastatic RCC patients as systemic radionuclide treatment option.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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

  • Progression after at least 2 lines of systemic therapy or existence of a contraindication to systemic therapies
  • At least 3 years of life expectancy
  • ECOG performance status ≤ 2
  • Ability to sign informed consent

排除标准

  • Not having received any systemic therapies
  • History of a secondary malignancy
  • ECOG performance status > 2
  • Any contraindication for radionuclide therapy (pregnancy, lactation, organ disfunction, metastatic lesions with a risk of compression
  • Previous history of any radionuclide therapies
  • Inability to sign informed consent

研究组 & 干预措施

Lu-PSMA treatment arm

Experimental

Patients who will received Lu-177 PSMA treatment for metastatic RCC

干预措施: Lu-177 PSMA-617 (Drug)

结局指标

主要结局

toxicity analysis

时间窗: 1-36 months

Therapy associated toxicity will be evaluated according to CTCAE V5.0 criteria.

次要结局

  • efficacy analysis(1-36 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cigdem Soydal

Prof of Nuclear Medicine

Ankara University

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