A Study of Suizenji in Patients With Unresectable Pancreatic Cancer

Unresectable Pancreatic Cancer Clinical Trial

Official title:

A Randomized Controlled Study of Suizenji in Patients With Unresectable Pancreatic Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05601323
• Other study ID #: Sonire-PAC-001
• Status: Recruiting
• Phase: N/A
• Start date: January 31, 2023
• Est. completion date: October 31, 2025

Study information

• Verified date: February 2024
• Source: SONIRE Therapeutics Inc.
• Contact: SONIRE Therapeutics Inc.
• Phone: +81-3-5843-6764
• Email: info[@]sonire-t.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: October 31, 2025
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatic Neoplasms
• Unresectable Pancreatic Cancer

Intervention

Device:
• Suizenji
HIFU treatment

Drug:
• Nal-IRI/FL
Nanoliposomal irinotecan, Fluorouracil, Levofolinate
• mFOLFIRINOX
Fluorouracil, Levofolinate, Irinotecan, Oxaliplatin
• Gem/nab-PTX
Gemcitabine, nab-Paclitaxel

Locations

Country	Name	City	State
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	Kanagawa Cancer Center	Yokohama-shi, Kanagawa
Japan	Yokohama City University Medical Center	Yokohama-shi, Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
SONIRE Therapeutics Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival		Up to approximately 24 months
Secondary	Progression-free survival		Up to approximately 12 months
Secondary	1-year survival rate		Up to approximately 12 months
Secondary	Objective response rate		Up to approximately 12 months
Secondary	Disease control rate		Up to approximately 12 months
Secondary	Adverse Events		Up to approximately 12 months