Prospective Observational Study to Assess the Effectiveness and Safety of Lanreotide Autogel® in Patients with Locally Advanced or Metastatic Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) in Asia Region
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Progression-free survival rate at 2 years
研究概览
简要总结
Lanreotide Autogel® has been established as a standard of care for patients with locally advanced or metastatic GEP-NETs based on the success of CLARINET trial. However, only few patients with Asian ethnicity were included in the trial.
According to the nationwide comprehensive study of patients with GEP-NET in Korea, hindgut primary NETs(Rectal) occured more frequently than western countries. However, small intestine or lung primary NET is relatively rare compared with western countries.1) Considering the clinical characteristics of GEP-NETs are distinct between the patients in Asian and Western countries, further evaluation on the efficacy and safety of Lanreotide Autogel® in Asian patients with GEP-NETs is needed.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Male or female subject aged ≥18 years and legally capable to provide informed consent
- •Functioning or non-functioning gastroenteropancreatic (GEP)-neuroendocrine tumor (NET) or unknown primary-NET
- •Well differentiated tumor
- •Grade (G) 1, G2 according to the 2017 World Health Organization (WHO) criteria
- •Subject already treated with Lanreotide Autogel® for the period up to 5 months, according to local standard of care, prior to documentation into this study
- •Use of Lanreotide autogel® monotherapy by local label (SmPC).
- •Concomitant locoregional therapy such as surgery, RFA or TAE is allowed.
排除标准
- •Parallel participation in an interventional study
- •Lanreotide treatment for more than 5 months prior inclusion into the study
- •Prior anti-proliferative medication with somatostatin analogue (e.g. Octreotide LAR).
- •Concomitant anti-proliferative systemic medication/therapies for GEP-NET are not allowed.
研究组 & 干预措施
Lanreotide
Patients treated with lanreotide
干预措施: Lanreotide autogel (Drug)
结局指标
主要结局
Progression-free survival rate at 2 years
时间窗: 2 years
Proportion of patients without tumor progression defined by RECIST version 1.1 at 2 years
次要结局
- Disease control rates(2 years)
- Progression-free survival(2 years)
- Response rates(2 years)
- Overall survival(2 years)
- Chromogranin A response(2 years)
研究者
Changhoon Yoo
Assistant Professor
Asan Medical Center