NCT07033689 Feasibility Study of Suizenji, in Patients With Unresectable Pancreatic Ductal Adenocarcinoma (SUNRISE-II)
| NCT ID | NCT07033689 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | SONIRE Therapeutics Inc. |
| Condition | Pancreatic Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2026-01-05 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2026-01-05 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
1. Signed an Institutional Review Board (IRB) approved informed consent document. 2. Men and women ≥ 18 years of age. 3. Histologically or cytologically diagnosed PDAC. 4. 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) 5. Primary tumor accessible to HIFU treatment and visualized on transabdominal ultrasonography. 6. Primary tumor site must be a measurable lesion according to RECIST version 1.1 at baseline. 7. ECOG Performance Status (ECOG-PS) of 0 - 1. 8. Life expectancy ≥ 3 months. 9. 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 Exclusion Criteria: 1. Subjects with any cancers other than PDAC who are on active treatment. 2. Subjects who had any prior chemotherapy or interventions for PDAC. 3. Obstructive jaundice (except for subjects who have a bile duct stent placed for obstructive jaundice prior to initiation of HIFU treatment). 4. Tumor embolization in the veins surrounding the pancreas. 5. 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. 6. 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. 7. Allergy to contrast agents (except when manageable by prophylactic steroid). 8. Subjects having a cardiac pacemaker. 9. Congestive heart failure, symptomatic coronary artery disease, arrhythmia poorly controlled by drugs, history of myocardial infarction or unstable angina within the past 6 months. 10. Subjects with peritoneal dissemination. 11. Active infections requiring systemic treatment. 12. Pregnancy or women of childbearing potential not willing to follow the birth control as described in the informed consent and/or who are breastfeeding. 13. Received unapproved or investigational drug or device within 30 days of the subject's study start date. 14. The judgment of the investigator would make the subject inappropriate for entry into the study.
Contact & Investigator
Pejman Ghanouni, MD
PRINCIPAL INVESTIGATOR
Stanford University
Frequently Asked Questions
Who can join the NCT07033689 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pancreatic Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07033689 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07033689 currently recruiting?
Yes, NCT07033689 is actively recruiting participants. Contact the research team at mkoga@kmphc.com for enrollment information.
Where is the NCT07033689 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT07033689 clinical trial?
NCT07033689 is sponsored by SONIRE Therapeutics Inc.. The principal investigator is Pejman Ghanouni, MD at Stanford University. The trial plans to enroll 10 participants.
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