Suizenji HIFU therapy for unresectable pancreatic ductal adenocarcinoma

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

This study will try an ultrasound-guided HIFU device called Suizenji to heat and shrink tumors in adults with unresectable pancreatic ductal adenocarcinoma before they start standard first-line chemotherapy.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: SONIRE Therapeutics Inc. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 1 site (San Francisco, California)
• Trial ID: NCT07033689 on ClinicalTrials.gov

What this trial studies

This is an open-label, non-randomized, single-center feasibility and safety study of the Suizenji ultrasound-guided high-intensity focused ultrasound (HIFU) system at Stanford. Eligible adults with newly diagnosed unresectable, locally advanced, or metastatic pancreatic ductal adenocarcinoma will receive HIFU ablation on Day 1 with a possible additional session if ablation is incomplete, followed by initiation of standard first-line chemotherapy (e.g., FOLFIRINOX, Gem/nab-PTX, or NALIRIFOX). The trial will collect safety, tolerability, technical success, and preliminary efficacy data with follow-up visits at 1 and 3 months and long-term follow-up up to 5 years. Key enrollment criteria include a measurable primary tumor visible on transabdominal ultrasound, ECOG 0–1, and adequate organ function.

Who should consider this trial

Good fit: Adults (≥18) with histologically or cytologically confirmed pancreatic ductal adenocarcinoma that is newly diagnosed and unresectable (not resectable or borderline resectable), with a measurable primary tumor visible by transabdominal ultrasound, ECOG 0–1, life expectancy ≥3 months, and adequate organ function are ideal candidates.

Not a fit: Patients with resectable or borderline-resectable tumors, tumors not accessible or not visualized by transabdominal ultrasound, ECOG ≥2, other active cancers on treatment, severe organ dysfunction, or life expectancy under 3 months are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, Suizenji could provide local tumor control or symptom relief, potentially improving outcomes and survival when combined with standard chemotherapy.

How similar studies have performed: High-intensity focused ultrasound has shown promise in small series for symptom relief and local tumor control in pancreatic cancer, but high-quality evidence for survival benefit is limited, and Suizenji is a newer system being tested for feasibility.

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.

Where this trial is running

San Francisco, California

• Stanford University — San Francisco, California, United States (Recruiting)

Study contacts

• Principal investigator: Pejman Ghanouni, MD — Stanford University
• Study coordinator: Minako Koga

Conditions Pancreatic Cancer; Pancreatic Cancer,