A Study of Suizenji in Patients With Unresectable Pancreatic Cancer

March 12, 2026 updated by: SONIRE Therapeutics Inc.

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Nagakute-shi, Aichi, Japan, 480-1195
        • Aichi Medical University Hospital
      • Sendai-shi, Miyagi, Japan, 980-8574
        • Tohoku University Hospital
      • Shinjuku-ku, Tokyo, Japan, 160-0023
        • Tokyo Medical University Hospita
      • Toyama-shi, Toyama, Japan, 930-0194
        • Toyama University Hospital
      • Wakayama-shi, Wakayama, Japan, 641-8510
        • Wakayama Medical University Hospital
      • Yokohama-shi, Kanagawa, Japan, 232-0024
        • Yokohama City University Medical Center
      • Yokohama-shi, Kanagawa, Japan, 241-8515
        • Kanagawa Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: Up to approximately 24 months
Up to approximately 24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival
Time Frame: Up to approximately 12 months
Up to approximately 12 months
1-year survival rate
Time Frame: Up to approximately 12 months
Up to approximately 12 months
Objective response rate
Time Frame: Up to approximately 12 months
Up to approximately 12 months
Disease control rate
Time Frame: Up to approximately 12 months
Up to approximately 12 months
Adverse Events
Time Frame: Up to approximately 12 months
Up to approximately 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SONIRE Therapeutics Inc.

Investigators

  • Study Director: SONIRE Therapeutics Inc., SONIRE Therapeutics Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2023

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

May 31, 2027

Study Registration Dates

First Submitted

October 27, 2022

First Submitted That Met QC Criteria

October 27, 2022

First Posted (Actual)

November 1, 2022

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sonire-PAC-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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