Actively Recruiting

Early Phase 1
Age: 18Years +
All Genders
NCT07033689

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

Led by SONIRE Therapeutics Inc. · Updated on 2026-04-03

10

Participants Needed

1

Research Sites

60 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed an Institutional Review Board (IRB) approved informed consent document.
  • Men and women 18 years of age or older.
  • Histologically or cytologically diagnosed pancreatic ductal adenocarcinoma (PDAC).
  • Newly diagnosed unresectable, locally advanced or metastatic disease.
  • 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 of 0 or 1.
  • Life expectancy of at least 3 months.
  • Adequate organ function including neutrophil count ≥ 1,500/mm3, platelet count ≥ 50,000/mm3, hemoglobin ≥ 8.0 g/dl, creatinine ≤ 1.7 mg/dl, AST and ALT ≤ 3 times the upper limit of normal, and total bilirubin ≤ 2 times the upper limit of normal.
Not Eligible

You will not qualify if you...

  • Active treatment for any cancers other than pancreatic ductal adenocarcinoma.
  • Prior chemotherapy or interventions for pancreatic ductal adenocarcinoma.
  • Obstructive jaundice without a bile duct stent placed prior to starting HIFU treatment.
  • Tumor embolization in veins around the pancreas.
  • Cysts outside the primary pancreatic tumor that block the HIFU pathway (unless cyst is fully surrounded by tumor).
  • More than 50% reduction in size of the main hepatic artery or occlusion of the portal vein seen on CT or MRI.
  • Allergy to contrast agents unless manageable by steroid treatment.
  • Having a cardiac pacemaker.
  • Congestive heart failure, poorly controlled arrhythmia, recent heart attack or unstable angina within 6 months.
  • Peritoneal dissemination.
  • Active infections requiring systemic treatment.
  • Pregnancy, breastfeeding, or women of childbearing potential unwilling to use birth control.
  • Use of unapproved or investigational drugs or devices within 30 days before study start.
  • Any other condition that investigator judges makes participation inappropriate.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Stanford University

San Francisco, California, United States, 94305

Actively Recruiting

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Research Team

M

Minako Koga

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DEVICE_FEASIBILITY

Number of Arms

1

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