A Study of Suizenji in Patients With Unresectable Pancreatic Cancer
NCT ID: NCT05601323
Last Updated: 2025-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
90 participants
INTERVENTIONAL
2023-01-31
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
Suizenji
HIFU treatment
Nal-IRI/FL
Nanoliposomal irinotecan, Fluorouracil, Levofolinate
mFOLFIRINOX
Fluorouracil, Levofolinate, Irinotecan, Oxaliplatin
Gem/nab-PTX
Gemcitabine, nab-Paclitaxel
Chemotherapy
Chemotherapy (physician's choice): Nal-IRI/FL, mFOLFIRINOX or Gem/nab-PTX
Nal-IRI/FL
Nanoliposomal irinotecan, Fluorouracil, Levofolinate
mFOLFIRINOX
Fluorouracil, Levofolinate, Irinotecan, Oxaliplatin
Gem/nab-PTX
Gemcitabine, nab-Paclitaxel
Interventions
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Suizenji
HIFU treatment
Nal-IRI/FL
Nanoliposomal irinotecan, Fluorouracil, Levofolinate
mFOLFIRINOX
Fluorouracil, Levofolinate, Irinotecan, Oxaliplatin
Gem/nab-PTX
Gemcitabine, nab-Paclitaxel
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
20 Years
ALL
No
Sponsors
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SONIRE Therapeutics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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SONIRE Therapeutics Inc.
Role: STUDY_DIRECTOR
SONIRE Therapeutics Inc.
Locations
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Aichi Medical University Hospital
Nagakute-shi, Aichi, , Japan
Tohoku University Hospital
Sendai-shi, Miyagi, , Japan
Tokyo Medical University Hospita
Shinjuku-ku, Tokyo, , Japan
Toyama University Hospital
Toyama-shi, Toyama, , Japan
Wakayama Medical University Hospital
Wakayama-shi, Wakayama, , Japan
Yokohama City University Medical Center
Yokohama-shi, Kanagawa, , Japan
Kanagawa Cancer Center
Yokohama-shi, Kanagawa, , Japan
Countries
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Central Contacts
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Other Identifiers
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Sonire-PAC-001
Identifier Type: -
Identifier Source: org_study_id
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