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

Starting soon · Not applicable

Conditions studied: Pancreatic Cancer, Borderline Resectable Pancreatic Cancer, Locally Advanced Pancreatic Cancer

In brief

The purpose of this Interventional clinical trial is to evaluate safety and efficacy of 'IMD10 (focused ultrasound)' in the treatment of borderline resectable pancreatic cancer or locally advanced pancreatic cancer.

Key facts

Study ID: NCT07325214
Run by: IMGT Co., Ltd.
People needed: 360
Starts: 2026-09-01
Expected to finish: 2030-01-01
Last updated by the study team: 2026-07-15

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 is running

Brigham and Women's Hospital — Boston, Massachusetts, United States
University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States
University of Virginia Medical Center — Charlottesville, Virginia, United States
Seoul National University Bundang Hospital, — Gyeonggi-do, South Korea
Seoul National University Hospital — Seoul, South Korea

Full record on ClinicalTrials.gov

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