NCT07033689RecruitingEarly phase 1

Feasibility Study of Suizenji, in Patients With Unresectable Pancreatic Ductal Adenocarcinoma (SUNRISE-II)

Open-label, Non-randomized, Single-center Study Investigating the Feasibility, Safety, Tolerability and Efficacy of Suizenji in Unresectable Pancreatic Ductal Adenocarcinoma Patients

Source: ClinicalTrials.gov · Last updated 3 Apr 2026

Brief summary (registry, in English)

This is a feasibility, safety, tolerability, and efficacy research study of an investigational device called "Suizenji", an ultrasound-guided high-intensity focused ultrasound (HIFU) therapy system for the treatment of unresectable pancreatic ductal adenocarcinoma. Focused ultrasound therapy uses a number of small ultrasound generators attached to a bowl-shaped ultrasound generator to emit ultrasound waves from outside to inside the body and focus them on a single point where cancerous cells in the pancreas are located. The targeted area is then heated, which kills the pancreatic cancer cells, and as a result, the patient's life may be prolonged. Experience with Suizenji for pancreatic cancer patients has shown that the "heating" is only a warm feeling in the abdomen during the treatment.

Status (registry): Recruiting
Phase (registry): Early phase 1
Study type: Interventional
Enrollment: 10 (estimated)
First submitted: 5 Jun 2025
Start date: 5 Jan 2026
Primary completion date: 1 Dec 2026
Lead sponsor: SONIRE Therapeutics Inc.
Diseases: Pancreatic cancer
NCT number: NCT07033689

What you commit to

Study type: Interventional · Early phase 1
Planned participants: 10
From 5 Jan 2026 to the primary completion date, 1 Dec 2026
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Subjects who had any prior chemotherapy or interventions for PDAC.
Obstructive jaundice (except for subjects who have a bile duct stent placed for obstructive jaundice prior to initiation of HIFU treatment).
Received unapproved or investigational drug or device within 30 days of the subject's study start date.

Other illness

Subjects with any cancers other than PDAC who are on active treatment.
Allergy to contrast agents (except when manageable by prophylactic steroid).
Subjects having a cardiac pacemaker.
Congestive heart failure, symptomatic coronary artery disease, arrhythmia poorly controlled by drugs, history of myocardial infarction or unstable angina within the past 6 months.
Active infections requiring systemic treatment.

Other

Tumor embolization in the veins surrounding the pancreas.
Cysts outside of primary pancreatic tumor which may obstruct the HIFU sonication pathway. However, if the cyst is completely surrounded by pancreatic tumor, the subject can be included.
Subjects with \> 50% reduction in caliber of the principal hepatic artery and occlusion of the portal vein seen on preoperative screening CT or MRI scan.
Subjects with peritoneal dissemination.
Pregnancy or women of childbearing potential not willing to follow the birth control as described in the informed consent and/or who are breastfeeding.
The judgment of the investigator would make the subject inappropriate for entry into the study.

Criteria the registry did not label

Signed an Institutional Review Board (IRB) approved informed consent document.
Men and women ≥ 18 years of age.
Histologically or cytologically diagnosed PDAC.
Newly diagnosed unresectable\*, locally advanced or metastatic disease. (\* defined as not "Resectable" and not "borderline resectable" based on "Criteria Defining Resectability at Diagnosis" in NCCN Guideline 2024)
Primary tumor accessible to HIFU treatment and visualized on transabdominal ultrasonography.
Primary tumor site must be a measurable lesion according to RECIST version 1.1 at baseline.
ECOG Performance Status (ECOG-PS) of 0 - 1.
Life expectancy ≥ 3 months.
Adequate organ function defined by:
- Neutrophil count: ≥ 1,500/mm3
- Platelet count: ≥ 50,000/mm3
- Hemoglobin: ≥ 8.0 g/dl
- Cr: ≤ 1.7 mg/dl
- AST, ALT: ≤ 3 x upper limit of normal
- T-Bil: ≤ 2 x upper limit of normal

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Stanford University Coordinator of this site? Confirm its status	San Francisco	United States	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.