Resection of Metastatic Pancreatic Neuroendocrine Tumors After Induction System Treatment: Real World Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- progression-free survival
研究概览
简要总结
This study is to evaluate the efficacy and tolerability of surgery in selecting patients who can benefit from the synchronous resection of primary pancreatic neuroendocrine tumor and liver metastasis after induction systemic treatment. The willing of participants decide who receive surgery and who will continue to receive standard systemic treatment.
详细描述
system treatments of metastatic PanNET include SSA, sunitinib, mTOR inhibitor and chemotherapy. For patients achieved PR/SD after system treatment, resection of primary tumor and metastasis maybe a better way to decline tumor burden and get longer survival. this real world study is focused on this group of patients with metastatic PanNET, and to evaluate the efficacy and tolerability of surgery in selecting patients who can benefit from the synchronous resection of primary pancreatic neuroendocrine tumor and liver metastasis after induction systemic treatment.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy-proven neuroendocrine tumor
- •primary site in pancreas
- •Advanced disease with lymph node or distant metastases (N1, M1) cannot undergoing cytoreduction by surgery/local ablative therapy at the diagnosis
- •curative intent of all therapies possible
排除标准
- •Undifferentiated neuroendocrine carcinoma or mixed neuroendocrine carcinoma secondary tumor
- •functioning NET or advanced carcinoid heart disease
- •part of hereditary syndrome, such as MEN1, VHL
- •do not willing to receive systemic treatment
- •diagnosed with other cancer within 5 years
结局指标
主要结局
progression-free survival
时间窗: 5 years
次要结局
- overall survival(5 years)
- Number of Postoperative morbidity(Up to 90 days after operation)
- number of Postoperative mortality(Up to 90 days after operation)
研究者
Xian-Jun Yu
Principal Investigator
Fudan University