NL-OMON52990招募中3 期
A prospective, randomised, controlled, open-label, multicentre phase III study to evaluate efficacy and safety of Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-Edotreotide compared to targeted molecular therapy with Everolimus in patients with inoperable, progressive, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin (GEP-NET). - The COMPETE Study
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Written informed consent
- •2. Male or female >=18 years of age
- •3. Histologically and clinically confirmed diagnosis of well-differentiated
- •neuroendocrine tumour of non-functional gastroenteric origin (GE-NET) or both
- •functional or non-functional pancreatic origin P-NET), grade G1 or G2 (Ki-67 <
- •20%), unresectable or metastatic, in a patient who is either treatment-naïve
- •(1st line) or who has progressed under prior therapy (2nd line)
排除标准
- •1. Known hypersensitivity to edotreotide or everolimus
- •2. Known hypersensitivity to DOTA, lutetium-177, or any excipient of
- •edotreotide or everolimus
- •3. Known hypersensitivity to lysin, arginin, or any excipient of the
- •nephroprotective amino acid solution
研究者
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