A Randomized Controlled Study of Suizenji in Patients With Unresectable Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 7
- 主要终点
- Overall Survival
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of standard chemotherapy with or without a novel High Intensity Focused Ultrasound system (Code: Suizenji) in patients with unresectable pancreatic cancer who are refractory or intolerant to first-line 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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 20 years and over.
- •Unresectable pancreatic cancer (including metastatic pancreatic cancer) who are refractory or intolerant to first-line chemotherapy. Any first-line chemotherapy is acceptable.
- •Target treatment tumor is located in the pancreas, and the target tumor can be visualized with ultrasound echography and can also be treated by high-intensity focused ultrasound.
- •Has primary tumor site of measurable lesion according to RECIST guidelines version 1.1
- •ECOG performance status of 0 to 2.
排除标准
- •Active multiple cancers that require treatment.
- •Suspected gastrointestinal invasion of the primary tumor based on CT scan.
- •Obstructive jaundice. However, patients who have a bile duct stent placed for obstructive jaundice by the time of allocation may be enrolled.
- •Child-Pugh Classification B or C liver failure due to liver metastases.
- •Tumor embolization in the veins surrounding the pancreas.
- •Cystic component within the pancreatic cancer.
- •Peritoneal dissemination.
- •Pleural effusion or ascites with poorly controlled
- •Contraindications to the use of secondary chemotherapy used in this study.
研究组 & 干预措施
HIFU (High-Intensity Focused Ultrasound) + Chemotherapy
HIFU treatment with Suizenji: up to 2 times per week (1 course) for pancreatic primary lesions; the second course should be at least 60 days apart, up to a maximum of 5 courses.
Chemotherapy (physician's choice): Nal-IRI/FL, mFOLFIRINOX or Gem/nab-PTX
干预措施: Suizenji (Device)
HIFU (High-Intensity Focused Ultrasound) + Chemotherapy
HIFU treatment with Suizenji: up to 2 times per week (1 course) for pancreatic primary lesions; the second course should be at least 60 days apart, up to a maximum of 5 courses.
Chemotherapy (physician's choice): Nal-IRI/FL, mFOLFIRINOX or Gem/nab-PTX
干预措施: Nal-IRI/FL (Drug)
HIFU (High-Intensity Focused Ultrasound) + Chemotherapy
HIFU treatment with Suizenji: up to 2 times per week (1 course) for pancreatic primary lesions; the second course should be at least 60 days apart, up to a maximum of 5 courses.
Chemotherapy (physician's choice): Nal-IRI/FL, mFOLFIRINOX or Gem/nab-PTX
干预措施: mFOLFIRINOX (Drug)
HIFU (High-Intensity Focused Ultrasound) + Chemotherapy
HIFU treatment with Suizenji: up to 2 times per week (1 course) for pancreatic primary lesions; the second course should be at least 60 days apart, up to a maximum of 5 courses.
Chemotherapy (physician's choice): Nal-IRI/FL, mFOLFIRINOX or Gem/nab-PTX
干预措施: Gem/nab-PTX (Drug)
Chemotherapy
Chemotherapy (physician's choice): Nal-IRI/FL, mFOLFIRINOX or Gem/nab-PTX
干预措施: Nal-IRI/FL (Drug)
Chemotherapy
Chemotherapy (physician's choice): Nal-IRI/FL, mFOLFIRINOX or Gem/nab-PTX
干预措施: mFOLFIRINOX (Drug)
Chemotherapy
Chemotherapy (physician's choice): Nal-IRI/FL, mFOLFIRINOX or Gem/nab-PTX
干预措施: Gem/nab-PTX (Drug)
结局指标
主要结局
Overall Survival
时间窗: Up to approximately 24 months
次要结局
- Disease control rate(Up to approximately 12 months)
- Objective response rate(Up to approximately 12 months)
- Adverse Events(Up to approximately 12 months)
- Progression-free survival(Up to approximately 12 months)
- 1-year survival rate(Up to approximately 12 months)