Unresectable Pancreatic CancerNCT05601323
A Study of Suizenji in Patients With Unresectable Pancreatic Cancer
A study testing Suizenji, Nal-IRI/FL and mFOLFIRINOX in people with Unresectable Pancreatic Cancer, run by SONIRE Therapeutics Inc. at 7 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Unresectable Pancreatic Cancer
- What is being tested?
- Suizenji, Nal-IRI/FL and mFOLFIRINOX
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 7 sitesJapan
- Study dates
- 31 Jan 2023to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Peritoneal dissemination.
- Pleural effusion or ascites with poorly controlled
- Contraindications to the use of secondary chemotherapy used in this study.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Japan7 sites
Aichi Medical University Hospital
Nagakute-shi, Aichi, 480-1195
Tohoku University Hospital
Sendai-shi, Miyagi, 980-8574
Tokyo Medical University Hospita
Shinjuku-ku, Tokyo, 160-0023
Toyama University Hospital
Toyama-shi, Toyama, 930-0194
Wakayama Medical University Hospital
Wakayama-shi, Wakayama, 641-8510
Yokohama City University Medical Center
Yokohama-shi, Kanagawa, 232-0024
Kanagawa Cancer Center
Yokohama-shi, Kanagawa, 241-8515
About this study
Official title: A Randomized Controlled Study of Suizenji in Patients With Unresectable Pancreatic Cancer
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.
- Conditions
- Unresectable Pancreatic Cancer
- Being tested
- Suizenji, Nal-IRI/FL, mFOLFIRINOX, Gem/nab-PTX
- Keywords
- Unresectable Pancreatic Cancer, Suizenji, high intensity focused ultrasound, HIFU
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuizenjiDevice
HIFU treatment
Nal-IRI/FLDrug
Nanoliposomal irinotecan, Fluorouracil, Levofolinate
mFOLFIRINOXDrug
Fluorouracil, Levofolinate, Irinotecan, Oxaliplatin
Gem/nab-PTXDrug
Gemcitabine, nab-Paclitaxel
| Study group | Role | What they receive |
|---|---|---|
| HIFU (High-Intensity Focused Ultrasound) + Chemotherapy | Experimental | 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 Receives: Device: Suizenji; Drug: Nal-IRI/FL; Drug: mFOLFIRINOX; Drug: Gem/nab-PTX |
| Chemotherapy | Active comparator | Chemotherapy (physician's choice): Nal-IRI/FL, mFOLFIRINOX or Gem/nab-PTX Receives: Drug: Nal-IRI/FL; Drug: mFOLFIRINOX; Drug: Gem/nab-PTX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: Up to approximately 24 months
Secondary outcomes (5)
Progression-free survival
Measured: Up to approximately 12 months
1-year survival rate
Measured: Up to approximately 12 months
Objective response rate
Measured: Up to approximately 12 months
Disease control rate
Measured: Up to approximately 12 months
Adverse Events
Measured: Up to approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start31 Jan 2023
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SONIRE Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- SONIRE Therapeutics Inc., Study director, SONIRE Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05601323
- Sponsor's protocol ID
- Sonire-PAC-001
- Status last verified
- Apr 2025
- First submitted
- 27 Oct 2022
- Last updated
- 16 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of Suizenji in Patients With Unresectable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT05601323
- Acronym / sponsor ID
- Sonire-PAC-001
- Conditions
- Unresectable Pancreatic Cancer
- Keywords
- Unresectable Pancreatic Cancer, Suizenji, high intensity focused ultrasound, HIFU
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- SONIRE Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 1 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIFU (High-Intensity Focused Ultrasound) + Chemotherapy | Experimental | Device: Suizenji, Drug: Nal-IRI/FL, Drug: mFOLFIRINOX, Drug: Gem/nab-PTXHIFU 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 |
| Chemotherapy | Active comparator | Drug: Nal-IRI/FL, Drug: mFOLFIRINOX, Drug: Gem/nab-PTXChemotherapy (physician's choice): Nal-IRI/FL, mFOLFIRINOX or Gem/nab-PTX |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SuizenjiHIFU treatment | Device | HIFU (High-Intensity Focused Ultrasound) + Chemotherapy |
| Nal-IRI/FLNanoliposomal irinotecan, Fluorouracil, Levofolinate | Drug | Chemotherapy, HIFU (High-Intensity Focused Ultrasound) + Chemotherapy |
| mFOLFIRINOXFluorouracil, Levofolinate, Irinotecan, Oxaliplatin | Drug | Chemotherapy, HIFU (High-Intensity Focused Ultrasound) + Chemotherapy |
| Gem/nab-PTXGemcitabine, nab-Paclitaxel | Drug | Chemotherapy, HIFU (High-Intensity Focused Ultrasound) + Chemotherapy |
Primary outcome
Overall Survival
Time frame: Up to approximately 24 months
5 secondary outcomes
Progression-free survival
Time frame: Up to approximately 12 months
1-year survival rate
Time frame: Up to approximately 12 months
Objective response rate
Time frame: Up to approximately 12 months
Disease control rate
Time frame: Up to approximately 12 months
Adverse Events
Time frame: Up to approximately 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SONIRE Therapeutics Inc. study director
SONIRE Therapeutics Inc.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suizenji, Nal-IRI/FL and mFOLFIRINOX in people with Unresectable Pancreatic Cancer, run by SONIRE Therapeutics Inc. at 7 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: Up to approximately 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.