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A Study of Suizenji in Patients With Unresectable Pancreatic Cancer

NCT05601323 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-03-16

No results posted yet for this study

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.

Conditions

  • Unresectable Pancreatic Cancer

Interventions

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

Sponsors & Collaborators

  • SONIRE Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • SONIRE Therapeutics Inc. · SONIRE Therapeutics Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-31
Primary Completion
2027-05-31
Completion
2027-05-31

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05601323 on ClinicalTrials.gov