Open-label, Non-randomized, Single-center Study Investigating the Feasibility, Safety, Tolerability and Efficacy of Suizenji in Unresectable Pancreatic Ductal Adenocarcinoma Patients
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.
• Signed an Institutional Review Board (IRB) approved informed consent document.
• Men and women ≥ 18 years of age.
• Histologically or cytologically diagnosed PDAC.
• 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)
• 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 (ECOG-PS) of 0 - 1.
• Life expectancy ≥ 3 months.
• 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