NCT04946305已完成不适用
A Post Marketing Surveillance on Lutathera® (Lutetium (177Lu) Oxodotreotide, 177Lu-DOTA0-Tyr3-Octreotate) in Patients With Somatostatin Receptor Positive Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET) in Korea
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events
研究概览
简要总结
This is a prospective, open-label, multi-center, non-comparative, non-interventional observational study to assess safety and effectiveness of Lutathera in patients with somatostatin receptor-positive GEP-NET in the real-world setting in Korea.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who start Lutathera treatment per clinical judgment, according to the locally approved labeling.
- •somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults.
- •Patients who are willing to provide written informed consent.
排除标准
- •Patients with contraindication according to prescribing information for Lutathera in Korea.
结局指标
主要结局
Incidence of Adverse Events
时间窗: Up to 36 weeks
Incidence of Adverse Events (AEs), Serious AE and unexpected AEs.
Incidence of Adverse Drug Reactions
时间窗: Up to 36 weeks
Incidence of Adverse Drug Reactions (ADRs), Serious ADRs and unexpected ADRs.
次要结局
- Effectiveness in terms of Overall Response Rate (ORR)(Up to 32 weeks (4 cycles of 8 weeks))
研究者
研究点 (1)
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