Real-world Effectiveness of Adjuvant Octreotide Therapy in High Recurrence Risk Patients With Pancreatic Neuroendocrine Tumors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 411
- 主要终点
- Disease-free survival time
研究概览
简要总结
Adjuvant therapy in pancreatic neuroendocrine tumors (pNETs) after radical resection lacks evidence-based data and is controversial. Real-world data were clustered to validate whether the long-acting octreotide is a potential candidate for adjuvant therapy in high recurrence risk G2 pNET patients.
详细描述
Adjuvant therapy for pNETs was proposed as an unmet clinical need by the European Neuroendocrine Tumor Society Group in 2016.1The Clinical Practice Guidelines for pNETs in China recommended initiation of clinical trials to investigate the role of adjuvant therapy for patients with a high-risk of recurrence. To address this unmet clinical need, the investigators initiated this real-world study. The aim of the current study was to assess the impact of octreotide LAR as an adjuvant therapy in reducing recurrence and prolonging survival in Chinese non-metastatic pNETs patients at risk for recurrence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pNETs lesions pathologically classified as WHO grade 2
- •Complete surgical resection (R0 or R1 was achieved)
- •Adjuvant treatment was performed within 12 weeks after surgery
排除标准
- •Other oncological history
- •Previous antineoplastic systemic therapy
- •Lack of information/details on recurrence or death.
研究组 & 干预措施
Octreotide group
Patients in the octreotide group received octreotide LAR (Sandostatin® LAR, Novartis Pharmaceuticals Corporation) treatment by deep intramuscular injection at a dose of 30 mg every 28 days for 6-12 months, with the start of clinical intervention following surgery.
干预措施: Octreotide LAR (Drug)
结局指标
主要结局
Disease-free survival time
时间窗: From the date of surgery to the date of distant metastasis or recurrence or death due to any cause, whichever came first, assessed up to 120 months
Disease-free survival time
次要结局
- Overall survival time(From the date of surgery to the date of death due to any cause, whichever came first, assessed up to 120 months)
研究者
Guo ShiWei
Clinical Professor
Changhai Hospital