Unresectable Pancreatic Cancer
Conditions
Keywords
Unresectable Pancreatic Cancer, Suizenji, high intensity focused ultrasound, HIFU
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.
Interventions
DEVICESuizenji
HIFU treatment
DRUGNal-IRI/FL
Nanoliposomal irinotecan, Fluorouracil, Levofolinate
DRUGmFOLFIRINOX
Fluorouracil, Levofolinate, Irinotecan, Oxaliplatin
DRUGGem/nab-PTX
Gemcitabine, nab-Paclitaxel
Sponsors
SONIRE Therapeutics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival | Up to approximately 24 months |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival | Up to approximately 12 months |
| 1-year survival rate | Up to approximately 12 months |
| Objective response rate | Up to approximately 12 months |
| Disease control rate | Up to approximately 12 months |
| Adverse Events | Up to approximately 12 months |
Countries
Japan
Contacts
STUDY_DIRECTORSONIRE Therapeutics Inc.
SONIRE Therapeutics Inc.
Outcome results
None listed