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

Inclusion criteria

• 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 Exclusion Criteria:
• 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.

Exclusion criteria

• 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.