Pancreatic CancerSonoPANIIINCT07325214
Chemotherapy With or Without IMD10 (Focused Ultrasound) in the Treatment of Borderline Resectable or Locally Advanced Pancreatic Cancer
A study testing IMD10 and chemotherapy regimen [irinotecan hydrochloride, oxaliplatin, fluorouracil (5-FU) and leucovorin] in people with Pancreatic Cancer and Borderline Resectable Pancreatic Cancer, run by IMGT Co., Ltd. at 5 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pancreatic Cancer, Borderline Resectable Pancreatic Cancer, Locally Advanced Pancreatic Cancer
- What is being tested?
- IMD10 and chemotherapy regimen [irinotecan hydrochloride, oxaliplatin, fluorouracil (5-FU) and leucovorin]
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Sep 2026to Jan 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 15Show fewer
- 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
Who cannot join
- 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.
Show all 22Show fewer
- 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
Trial locations and contacts
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 2 countries
United States3 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Jiping Wang, M.D.
University of Virginia Medical Center
Charlottesville, Virginia, 22908
Allan Tsung, M.D.
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Richard Tuli, M.D.
South Korea2 sites
Seoul National University Bundang Hospital,
Gyeonggi-do, 13620
Jinhyeok Hwang, M.D.
Seoul National University Hospital
Seoul, 03080
Jaeyoung Lee, M.D.
About this study
Official title: A Randomized, Multicenter, Multiregional, Pivotal Clinical Trial to Evaluate the Safety and Efficacy of IMD10 (Focused Ultrasound) in Combination With the Chemotherapy Regimen Consisting of Irinotecan Hydrochloride, Oxaliplatin, Fluorouracil (5-FU) and Leucovorin Improves Overall Survival Compared With the Chemotherapy Regimen Alone in Patients With Borderline Resectable Pancreatic Cancer or Locally Advanced Pancreatic Cancer
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.
Read the detailed description
- Background: Pancreatic Cancer (PaC) ranks as the 5th most common cause of cancer-related deaths in the Western world. Despite medical advances, PaC continues to have a dismal 5-year survival rate of only 8%. Since the pancreas is in the retroperitoneal cavity, there are few specific symptoms in the early stages, and cancer tissue grows relatively quickly, meaning it is often already advanced at the time of diagnosis.
- Study Design: This is a multinational, randomized, pivotal clinical trial conducted at multiple sites in the United States and the Republic of Korea. Eligible participants will be randomized in a 1:1 ratio to experimental group or control group.
- Interventions: Participants in the experimental group will receive chemotherapy regimen [irinotecan hydrochloride, oxaliplatin, fluorouracil (5-FU) and leucovorin] with IMD10.
Participants in the control group will receive chemotherapy regimen [irinotecan hydrochloride, oxaliplatin, fluorouracil (5-FU) and leucovorin] alone.
- Outcome Measures: The primary outcome measure is overall survival. Overall survival (OS) is defined as the time from the date of randomization to the date of death due to any cause. For participants still alive at the time of analysis, the OS time is censored on the last date the participants were known to be alive.
- Follow-up: Participants will be followed for safety and survival until the end of study.
- Conditions
- Pancreatic Cancer, Borderline Resectable Pancreatic Cancer, Locally Advanced Pancreatic Cancer
- Being tested
- IMD10, chemotherapy regimen [irinotecan hydrochloride, oxaliplatin, fluorouracil (5-FU) and leucovorin]
- Keywords
- Focused Ultrasound
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMD10Device
A non-thermal/non-tissue destructive Focused Ultrasound (FUS) device
chemotherapy regimen [irinotecan hydrochloride, oxaliplatin, fluorouracil (5-FU) and leucovorin]Drug
Chemotherapy regimen consisting of irinotecan hydrochloride, oxaliplatin, fluorouracil (5-FU) and leucovorin
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The experimental group receives IMD10 combined with the chemotherapy regimen [irinotecan hydrochloride, oxaliplatin, fluorouracil (5-FU) and leucovorin]. Receives: Device: IMD10; Drug: chemotherapy regimen [irinotecan hydrochloride, oxaliplatin, fluorouracil (5-FU) and leucovorin] |
| Control group | Active comparator | The control group receives the chemotherapy regimen [irinotecan hydrochloride, oxaliplatin, fluorouracil (5-FU) and leucovorin] alone, the same regimen administered to the experimental group. Receives: Drug: chemotherapy regimen [irinotecan hydrochloride, oxaliplatin, fluorouracil (5-FU) and leucovorin] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: From the date of the first trial participant's randomization to 24 months after the last trial participant's randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study startSep 2026 (estimated)
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IMGT Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07325214
- Sponsor's protocol ID
- IMG-D01-31
- Acronym
- SonoPANIII
- Status last verified
- Jul 2026
- First submitted
- 6 Jan 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes