Simultaneous Resection of Pancreatic Cancer and Liver Oligometastasis After Induction Chemotherapy
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Real overall survival
研究概览
简要总结
This study is a multi-center phase 3 trial to evaluate a treatment strategy for selecting patients who can benefit from the synchronous resection of primary pancreatic cancer and liver oligometastasis after induction chemotherapy. Half of participants who meet the entry criterion will receive surgical intervention, while the other half will continue to receive standard chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Standard treatment
Patients continue to receive standard chemotherapy.
干预措施: Standard chemotherapy (Drug)
Surgical exploration
Patients receive surgical exploration and synchronous resection of primary pancreatic cancer and liver oligometastasis will be performed.
干预措施: Synchronous resection of primary pancreatic cancer and liver oligometastasis (Procedure)
结局指标
主要结局
Real overall survival
时间窗: Up to 2 years
Including the time of induction chemotherapy
次要结局
- Overall survival(Up to 2 years)
- Life quality score(Up to 2 years, every 2 months)
- Postoperative morbidity(Up to 90 days after operation)
- Postoperative mortality(Up to 90 days after operation)
研究者
Xian-Jun Yu
Chair of Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center
Fudan University