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A Study of Suizenji in Patients With Unresectable Pancreatic Cancer

Primary Purpose

Unresectable Pancreatic Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Suizenji
Nal-IRI/FL
mFOLFIRINOX
Gem/nab-PTX
Sponsored by
SONIRE Therapeutics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unresectable Pancreatic Cancer focused on measuring Unresectable Pancreatic Cancer, Suizenji, high intensity focused ultrasound, HIFU

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tohoku University HospitalRecruiting
  • Tokyo Medical University HospitaRecruiting
  • Yokohama City University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HIFU (High-Intensity Focused Ultrasound) + Chemotherapy

Chemotherapy

Arm Description

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

Chemotherapy (physician's choice): Nal-IRI/FL, mFOLFIRINOX or Gem/nab-PTX

Outcomes

Primary Outcome Measures

Overall Survival

Secondary Outcome Measures

Progression-free survival
1-year survival rate
Objective response rate
Disease control rate
Adverse Events

Full Information

First Posted
October 27, 2022
Last Updated
June 15, 2023
Sponsor
SONIRE Therapeutics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05601323
Brief Title
A Study of Suizenji in Patients With Unresectable Pancreatic Cancer
Official Title
A Randomized Controlled Study of Suizenji in Patients With Unresectable Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 31, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SONIRE Therapeutics Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unresectable Pancreatic Cancer
Keywords
Unresectable Pancreatic Cancer, Suizenji, high intensity focused ultrasound, HIFU

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HIFU (High-Intensity Focused Ultrasound) + Chemotherapy
Arm Type
Experimental
Arm Description
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
Arm Title
Chemotherapy
Arm Type
Active Comparator
Arm Description
Chemotherapy (physician's choice): Nal-IRI/FL, mFOLFIRINOX or Gem/nab-PTX
Intervention Type
Device
Intervention Name(s)
Suizenji
Intervention Description
HIFU treatment
Intervention Type
Drug
Intervention Name(s)
Nal-IRI/FL
Intervention Description
Nanoliposomal irinotecan, Fluorouracil, Levofolinate
Intervention Type
Drug
Intervention Name(s)
mFOLFIRINOX
Intervention Description
Fluorouracil, Levofolinate, Irinotecan, Oxaliplatin
Intervention Type
Drug
Intervention Name(s)
Gem/nab-PTX
Intervention Description
Gemcitabine, nab-Paclitaxel
Primary Outcome Measure Information:
Title
Overall Survival
Time Frame
Up to approximately 24 months
Secondary Outcome Measure Information:
Title
Progression-free survival
Time Frame
Up to approximately 12 months
Title
1-year survival rate
Time Frame
Up to approximately 12 months
Title
Objective response rate
Time Frame
Up to approximately 12 months
Title
Disease control rate
Time Frame
Up to approximately 12 months
Title
Adverse Events
Time Frame
Up to approximately 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
SONIRE Therapeutics Inc.
Phone
+81-50-3733-1000
Email
info@sonire-t.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SONIRE Therapeutics Inc.
Organizational Affiliation
SONIRE Therapeutics Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Tohoku University Hospital
City
Sendai-shi, Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokyo Medical University Hospita
City
Shinjuku-ku, Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Individual Site Status
Recruiting
Facility Name
Yokohama City University Medical Center
City
Yokohama-shi, Kanagawa
ZIP/Postal Code
232-0024
Country
Japan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study of Suizenji in Patients With Unresectable Pancreatic Cancer

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