CTIS2024-510812-64-00招募中1 期
A Prospective, Randomized, Controlled, Open-label, Multicenter Trial to Evaluate Efficacy, Safety and Patient-reported Outcomes of Peptide Receptor Radionuclide Therapy (PRRT) with Lutetium (177Lu) Edotreotide compared to Best Standard of Care in Patients with Well-differentiated Aggressive Grade 2 and Grade 3, Somatostatin Receptor-positive (SSTR+), Neuroendocrine Tumors of GastroEnteric or Pancreatic Origin - DP-1111-02CT
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 202
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. Patients aged =18 years., 2. Histologically confirmed diagnosis of unresectable, well-differentiated GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs). measurable site of disease per RECIST v1.1 (Response evaluation criteria in solid tumors) using contrast computed tomography (CT) / magnetic resonance imaging (MRI)., 3. Somatostatin receptor-positive (SSTR+) disease.
排除标准
- •1. Known hypersensitivity to Lutetium 177Lu, edotreotide, DOTA (dodecane tetraacetic acid), any of the comparators, or any excipient or derivative (e.g. rapamycin)., 2. Prior (Peptide Receptor Radionuclide Therapy) PRRT., 3. Any major surgery within 4 weeks prior to randomization in the trial., 4. Therapy with an investigational compound and/or medical device within 30 days or 7 half-life periods (whichever is longer) prior to randomization., 5. Other known malignancies., 6. Serious non-malignant disease., 7. Renal, hepatic, cardiovascular, or hematological organ dysfunction, potentially interfering with the safety of the trial treatments., 8. Pregnant or breastfeeding women., 9. Patients not able to declare meaningful informed consent on their own or any other vulnerable population to that.
研究者
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