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Sound waves take on tough pancreatic cancer

NCT ID NCT05601323

Disease control Sponsor: SONIRE Therapeutics Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding a special ultrasound device called Suizenji to standard chemotherapy helps people with advanced pancreatic cancer that didn't respond to initial treatment. About 90 adults whose cancer cannot be removed by surgery will receive either chemo alone or chemo plus the ultrasound treatment. The goal is to see if the combination improves survival and controls the disease better.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2023

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

exocrine pancreatic carcinoma malignant pancreatic neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Unresectable pancreatic cancer

Contacts and locations

Locations

  • Aichi Medical University Hospital

    Nagakute-shi, Aichi, 480-1195, Japan

  • Kanagawa Cancer Center

    Yokohama-shi, Kanagawa, 241-8515, Japan

  • Tohoku University Hospital

    Sendai-shi, Miyagi, 980-8574, Japan

  • Tokyo Medical University Hospita

    Shinjuku-ku, Tokyo, 160-0023, Japan

  • Toyama University Hospital

    Toyama-shi, Toyama, 930-0194, Japan

  • Wakayama Medical University Hospital

    Wakayama-shi, Wakayama, 641-8510, Japan

  • Yokohama City University Medical Center

    Yokohama-shi, Kanagawa, 232-0024, Japan

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