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

NCT07033689 | Not Yet Recruiting Early Phase 1 DMC FDA Device

• 1 other identifier: Sonire-PAC-002
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Pancreatic Cancer

Keywords

Pancreatic Cancer,; Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Technical success for device feasibility

  Technical success of the HIFU ablation defined as \> 50% of treated volume assessed by MRI and/or contrast-enhanced CT after the last HIFU. Change from Baseline.

  3 Months

Secondary Outcomes (7)

• Clinical Efficacy

  3 Months

• Tumor volume

  3 Months

• Disease Control Rate

  3 months

• Tumor Marker

  3 months

• FDG-PET

  3 months

Study Arms (1)

Suizenji (an ultrasound-guided HIFU therapy system)

EXPERIMENTAL

Suizenji (an ultrasound-guided HIFU therapy system)

Device: Suizenji (an ultrasound-guided HIFU therapy system); Drug: Nal-IRI/FL; Drug: mFOLFIRINOX adjuvant chemotherapy; Drug: Gem/nab-PTX

Interventions

Suizenji (an ultrasound-guided HIFU therapy system) DEVICE

Suizenji (an ultrasound-guided HIFU therapy system)

Also known as: ultrasound-guided HIFU therapy system

Suizenji (an ultrasound-guided HIFU therapy system)

Nal-IRI/FL DRUG

Standard of care

Suizenji (an ultrasound-guided HIFU therapy system)

mFOLFIRINOX adjuvant chemotherapy DRUG

standard of care

Suizenji (an ultrasound-guided HIFU therapy system)

Gem/nab-PTX DRUG

standard of care

Suizenji (an ultrasound-guided HIFU therapy system)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Subjects with any cancers other than PDAC who are on active 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).
• 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.
• 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.
• Subjects with peritoneal dissemination.
• Active infections requiring systemic treatment.
• Pregnancy or women of childbearing potential not willing to follow the birth control as described in the informed consent and/or who are breastfeeding.
• Received unapproved or investigational drug or device within 30 days of the subject's study start date.
• The judgment of the investigator would make the subject inappropriate for entry into the study.

Sponsors & Collaborators

• SONIRE Therapeutics Inc.: lead

Study Sites (1)

Stanford University

San Francisco, California, 94305, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Pejman Ghanouni, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Minako Koga

CONTACT

202-615-6004; mkoga@kmphc.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Suizenji (an ultrasound-guided HIFU therapy system)

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 24, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: August 14, 2025

Record last verified: 2025-06

Locations

US (1)