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

Korábbi kezelés

• 2. Extensive scars or surgical clips observed in the region through which the ultrasound beam will pass
• 13. Participating in another drug/device clinical trial or have participated in another drug/device clinical trial within 4 weeks of C1D1

Más betegség

• 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, or ongoing receipt at the time of screening, of anti-tumor therapy for pancreatic cancer including chemotherapy, radiation, and/or surgery
• 8. A cardiovascular condition at the time of the screening visit that deems trial participation inappropriate due to one or more of the following:
  • Class III or IV heart failure according to New York Heart Association (NYHA) classification
  • Acute coronary syndrome (unstable angina or myocardial infarction) within the last 24 weeks --③ Uncontrolled heart arrhythmia
  • 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:
  • Other uncontrolled chronic infectious diseases
  • Active autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, ulcerative colitis, Crohn's disease, multiple sclerosis, ankylosing spondylitis, etc.)
  • Congenital or acquired immunodeficiency diseases, such as cellular immunodeficiency, hypogammaglobulinemia, and hypergammaglobulinemia.
  • Clinically significant mental illness
• 10. Known history of malignancies other than pancreatic cancer within the last 2 years
• 11. Known history of major surgery within 4 weeks of the cycle 1 day 1 (C1D1)

Egyéb

• 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.
• 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.
• 12. Pregnant and breastfeeding women
• 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

• An individual must meet all the following criteria:
• -1. Willing and able to understand and sign an ICF and to comply with all aspects of the protocol
• 2. Aged between 18 and 85 years, inclusive
• 3. Histologically or cytologically, pathologically confirmed diagnosis of PDAC.
• 4. Classification as BRPC or LAPC according to the NCCN Guidelines (The latest Edition) by radiologic test (CT or MRI), eligible for chemotherapy regimen within 4 weeks of the screening visit
• 5. Must have at least 1 measurable lesion per RECIST 1.1 criteria at the screening visit.
• 6. The ECOG performance status 0 or 1
• 7. Trial participant having laboratory values defined as:
  • -- Neutrophil count ≥ 1.5 x 109/L
  • Platelet count ≥ 100 x 109/L
  • AST and ALT ≤ 2.5 x ULN
  • Serum creatinine ≤ 1.5 x ULN
• 8. Life expectancy is more than 12 weeks
• 9. A female is eligible to trial participate if not pregnant, not breast feeding -and either a woman not of childbearing potential or, if a woman of childbearing potential agrees to use highly effective methods of contraception from screening to EOS
• 10. A male trial participant with female partner(s) of childbearing potential agrees to use highly effective methods of contraception from screening to EOS