Chemotherapy With IMD10 (Focused Ultrasound) for Borderline Resectable or Locally Advanced Pancreatic Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multinational randomized trial comparing chemotherapy alone to chemotherapy plus IMD10 focused ultrasound in adults with Borderline Resectable or Locally Advanced pancreatic cancer. Participants receive the same chemotherapy drugs (irinotecan, oxaliplatin, 5-FU, and leucovorin) in both arms, with the experimental arm also getting IMD10. The primary outcome is overall survival, with safety and other data collected throughout the study. Eligible patients must have measurable disease, good performance status, adequate organ function, and life expectancy longer than 12 weeks. The study aims to determine if IMD10 can improve outcomes when added to standard chemotherapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

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, 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)
* 12\. Pregnant and breastfeeding women
* 13\. 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

Where it's running

• University of Virginia Medical Center
  Charlottesville, Virginia, United States Recruiting
• Brigham and Women's Hospital
  Boston, Massachusetts, United States Not yet recruiting
• University of Texas Health Science Center at San Antonio
  San Antonio, Texas, United States Not yet recruiting
• Seoul National University Bundang Hospital,
  Gyeonggi-do, South Korea Not yet recruiting
• Seoul National University Hospital
  Seoul, South Korea Not yet recruiting

Study contacts

• Study coordinator: Jeongmin Jang
• Email: jeongmin.jang@nanoimgt.com
• Phone: +82-70-5080-2438

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.