Open-label, Non-randomized, Single-center Study Investigating the Feasibility, Safety, Tolerability and Efficacy of Suizenji in Unresectable Pancreatic Ductal Adenocarcinoma Patients
SONIRE Therapeutics Inc.
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.
Description
Study Title An Open-label, Non-randomized, Single-center Study Investigating the Feasibility, Safety, Tolerability and Efficacy of Suizenji, an Ultrasound-guided HIFU Therapy System, in Patients with Unresectable Pancreatic Ductal Adenocarcinoma (SUNRISE-II) Objectives Primary objectives 1. To evaluate the safety and tolerability of Suizenji. Secondary objectives 2. To evaluate the overall performance of Suizenji. 3. To explore technical success and preliminary clinical efficacy of Suizenji. Trial Stages Feasibility study Investigational site Stanford Cancer Institute Study Design This is an…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 S…
Interventions
- DeviceSuizenji (an ultrasound-guided HIFU therapy system)
Suizenji (an ultrasound-guided HIFU therapy system)
- DrugNal-IRI/FL
Standard of care
- DrugmFOLFIRINOX adjuvant chemotherapy
standard of care
- DrugGem/nab-PTX
standard of care
Location
- Stanford UniversitySan Francisco, California