Chemotherapy With or Without IMD10 (Focused Ultrasound) in the Treatment of Borderline Resectable or Locally Advanced Pancreatic Cancer

Exclusion Criteria

• •An individual who meets any of the following criteria will be excluded from participating in this clinical trial:
• •1\. The presence of a cystic lesion within tumor to be treated, or at the pancreas adjacent to the treated tumor.
• •2\. Extensive scars or surgical clips observed in the region through which the ultrasound beam will pass
• •3\. Targeted tumor(s) is not clearly visible with IMD10.
• •4\. Tumor is not treatable by the working range of IMD10
• •5\. Patient has difficulty in lying in supine position
• •6\. Known history of severe hypersensitivity to ultrasound gel or to chemotherapies (irinotecan hydrochloride, oxaliplatin, fluorouracil (5-FU) and leucovorin) used in this clinical trial
• •7\. Known history of another anti-tumor therapy including chemotherapy, radiation, and/or surgery for pancreatic cancer
• •8\. A cardiovascular condition at the time of the screening visit that deems trial participation inappropriate due to one or more of the following: ① Class III or IV heart failure according to New York Heart Association (NYHA) classification, ② Acute coronary syndrome (unstable angina or myocardial infarction) within the last 24 weeks, ③ Uncontrolled heart arrhythmia, ④ Other clinically significant cardiovascular abnormalities as determined by the investigator
• •9\. Known history at the time of the screening visit that deems trial participation inappropriate due to one or more of the following: ① Other uncontrolled chronic infectious diseases, ② Active autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, ulcerative colitis, Crohn's disease, multiple sclerosis, ankylosing spondylitis, etc.), ③ Congenital or acquired immunodeficiency diseases, such as cellular immunodeficiency, hypogammaglobulinemia, and hypergammaglobulinemia., ④ Clinically significant mental illness
• •10\. Known history of malignancies other than pancreatic cancer within the last 2 years, except for adequately treated basal cell or squamous cell skin cancer or carcinoma in situ (e.g., breast, cervix)
• •11\. Known history of major surgery within 4 weeks of the cycle 1 day 1 (C1D1)
• •12\. Pregnant and breastfeeding women
• •13\. Trial participating in another drug/device clinical trial or have participated in another drug/device clinical trial within 4 weeks of C1D1
• •14\. Trial participation in the clinical trial is deemed inappropriate at the investigator's discretion, either for ethical reasons or due to potential impact on the clinical trial's outcome