CTIS2023-510444-21-00进行中（未招募）1 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). - ITM-LET-01
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 324
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
- •1. Written informed consent, 2. Male or female =18 years of age, 3. Histologically confirmed diagnosis of well-differentiated neuro-endocrine tumour of non-functional gastroenteric origin (GE-NET) or both functional or non-functional pancreatic origin (P-NET), 4. Measurable disease per RECIST 1.1, 5. Somatostatin receptor positive (SSTR+) disease, 6. Progressive disease based on RECIST 1.1. criteria as evidenced by two morphological imaging examinations made with the same imaging method (either CT or MRI)
排除标准
- •1. Known hypersensitivity to edotreotide or everolimus, 10. Clinically relevant renal, hepatic, cardiovascular, or haematological organ dysfunction, potentially interfering with the safety of the study treatments, 11. Pregnant or breast-feeding women, 12. Subjects not able to declare meaningful informed consent on their own (e.g. with legal guardian for mental disorders) or any other vulnerable population to that sense (e.g. persons institutionalised, incarcerated etc.), 2. Known hypersensitivity to DOTA, lutetium-177, or any excipient of edotreotide or everolimus or any other Rapamycin derivative., 3. Prior exposure to any peptide receptor radionuclide therapy (PRRT), 4. Prior therapy with mTor inhibitors, 5. Prior EFR (external field radiation) to GEP-NET lesions within 90 days before randomisation or radioembolisation therapy., 6. Therapy with an investigational compound and/or medical device within 30 days prior to randomization, 7. Indication for surgical lesion removal with curative potential, 8. Planned alternative therapy (for the period of study participation), 9. Serious non-malignant disease
研究者
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