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Chemotherapy with Focused Ultrasound for Pancreatic Cancer

This study is looking at a new way to treat pancreatic cancer that is borderline resectable (meaning it's on the edge of being removable by surgery) or locally advanced (meaning it has spread to nearby tissues but not distant parts of the body). It combines standard chemotherapy (irinotecan hydrochloride, oxaliplatin, fluorouracil, and leucovorin) with a device called IMD10, which uses focused ultrasound. Researchers want to see if adding IMD10 to chemotherapy is safe and effective. You might be able to join if you are between 18 and 85 years old and have a confirmed diagnosis of pancreatic cancer. The main goal is to see if this combination helps people live longer. The current status of the study is unclear, but it plans to enroll 360 participants.

Study design
This is a multinational, randomized study where participants will be assigned by chance to either receive chemotherapy with IMD10 or chemotherapy alone. The study plans to enroll 360 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed to measure overall survival for up to 24 months after the last participant is enrolled.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07325214

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

Not Yet Recruiting
NAAges 18–85InterventionalTreatment
IMGT Co., Ltd.
~360 participants
Updated 2026-07-15 on ClinicalTrials.gov
What's tested:IMD10chemotherapy regimen [irinotecan hydrochloride, oxaliplatin, fluorouracil (5-FU) and leucovorin]

At a glance

Recruiting sites
0 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Survival
Measured over From the date of the first trial participant's randomization to 24 months after the last trial participant's randomization

Conditions

Pancreatic Cancer
Borderline Resectable Pancreatic Cancer
Locally Advanced Pancreatic Cancer

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Where you'd take part

This study runs at 5 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Brigham and Women's Hospital

    Boston, Massachusettsno site contact published

  • Seoul National University Bundang Hospital,

    Gyeonggi-do, South Koreano site contact published

  • Seoul National University Hospital

    Seoul, South Koreano site contact published

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texasno site contact published

  • University of Virginia Medical Center

    Charlottesville, Virginiano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Jeongmin Jang
[email protected]
+82-70-5080-2438
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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:
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

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

What this trial measures

  • Overall SurvivalFrom the date of the first trial participant's randomization to 24 months after the last trial participant's randomization