A Randomized Controlled Study of Suizenji in Patients With Unresectable Pancreatic Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- SONIRE Therapeutics Inc.
- Enrollment
- 90
- Locations
- 7
- Primary Endpoint
- Overall Survival
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Chemotherapy
Chemotherapy (physician's choice): Nal-IRI/FL, mFOLFIRINOX or Gem/nab-PTX
Intervention: Nal-IRI/FL (Drug)
Chemotherapy
Chemotherapy (physician's choice): Nal-IRI/FL, mFOLFIRINOX or Gem/nab-PTX
Intervention: mFOLFIRINOX (Drug)
Chemotherapy
Chemotherapy (physician's choice): Nal-IRI/FL, mFOLFIRINOX or Gem/nab-PTX
Intervention: Gem/nab-PTX (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
Intervention: 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
Intervention: 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
Intervention: Gem/nab-PTX (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
Intervention: Suizenji (Device)
Outcomes
Primary Outcomes
Overall Survival
Time Frame: Up to approximately 24 months
Secondary Outcomes
- 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)