Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05601323

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Unresectable Pancreatic Cancer

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aichi Medical University Hospital, Nagakute-shi, Aichi, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Suizenji

Device

HIFU treatment

Nal-IRI/FL

Drug

Nanoliposomal irinotecan, Fluorouracil, Levofolinate

mFOLFIRINOX

Drug

Fluorouracil, Levofolinate, Irinotecan, Oxaliplatin

Gem/nab-PTX

Drug

Gemcitabine, nab-Paclitaxel

Primary outcomes

  1. Overall Survival

    Time frame: Up to approximately 24 months

Secondary outcomes

  1. Progression-free survival

    Time frame: Up to approximately 12 months

  2. 1-year survival rate

    Time frame: Up to approximately 12 months

  3. Objective response rate

    Time frame: Up to approximately 12 months

  4. Disease control rate

    Time frame: Up to approximately 12 months

  5. Adverse Events

    Time frame: Up to approximately 12 months

Sponsors and collaborators

Lead sponsor

SONIRE Therapeutics Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Nov 1, 2022
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.