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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05601323
Other study ID # Sonire-PAC-001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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