A Study Of Suizenji In Patients With Unresectable Pancreatic Cancer

Study Overview

A 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.

N/A

Unresectable Pancreatic Cancer

DEVICE: Suizenji
DRUG: Nal-IRI/FL
DRUG: mFOLFIRINOX
DRUG: Gem/nab-PTX

Sonire-PAC-001

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2022-10-27	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-04-02
First Submitted that Met QC Criteria 2022-10-27	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-04-06
First Posted (ACTUAL) 2022-11-01	Results First Posted N/A	Last Verified 2025-04

Study Plan

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

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

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-P	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	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

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-P

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

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

Primary Outcome Measures	Measure Description	Time Frame
Overall Survival		Up to approximately 24 months

Secondary Outcome Measures	Measure Description	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

Contacts and Locations

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

Study Contact

Name: SONIRE Therapeutics Inc.

Phone Number: +81-3-5843-6764

Email: info@sonire-t.com

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
20 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

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

Investigators

STUDY_DIRECTOR: SONIRE Therapeutics Inc., SONIRE Therapeutics Inc.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record