A Study of Suizenji in Patients With Unresectable Pancreatic Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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 |
Device: Suizenji
HIFU treatment
Drug: Nal-IRI/FL
Nanoliposomal irinotecan, Fluorouracil, Levofolinate
Drug: mFOLFIRINOX
Fluorouracil, Levofolinate, Irinotecan, Oxaliplatin
Drug: Gem/nab-PTX
Gemcitabine, nab-Paclitaxel
|
| Active Comparator: Chemotherapy Chemotherapy (physician's choice): Nal-IRI/FL, mFOLFIRINOX or Gem/nab-PTX |
Drug: Nal-IRI/FL
Nanoliposomal irinotecan, Fluorouracil, Levofolinate
Drug: mFOLFIRINOX
Fluorouracil, Levofolinate, Irinotecan, Oxaliplatin
Drug: Gem/nab-PTX
Gemcitabine, nab-Paclitaxel
|
Outcome Measures
Primary Outcome Measures
- Overall Survival [Up to approximately 24 months]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tohoku University Hospital | Sendai-shi, Miyagi | Japan | 980-8574 | |
| 2 | Tokyo Medical University Hospita | Shinjuku-ku, Tokyo | Japan | 160-0023 | |
| 3 | Yokohama City University Medical Center | Yokohama-shi, Kanagawa | Japan | 232-0024 |
Sponsors and Collaborators
- SONIRE Therapeutics Inc.
Investigators
- Study Director: SONIRE Therapeutics Inc., SONIRE Therapeutics Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Sonire-PAC-001