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

January 8, 2026 updated by: IMGT Co., Ltd.

A Randomized Pivotal Clinical Trial Evaluating Chemotherapy Regimen Consisting of Irinotecan Hydrochloride, Oxaliplatin, Fluorouracil (5-FU) and Leucovorin With or Without IMD10 (Focused Ultrasound) in the Treatment of 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

136

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • South Korea
      • Gyeonggi-do, South Korea, 13620
        • Seoul National University Bundang Hospital,
        • Contact:
          • Jinhyeok Hwang, M.D.
      • Seoul, South Korea, 03080
        • Seoul National University Hospital
        • Contact:
          • Jaeyoung Lee, M.D.
  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
        • Contact:
          • Jiping Wang, M.D.
    • Texas
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Science Center at San Antonio
        • Contact:
          • Richard Tuli, M.D.
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Medical Center
        • Contact:
          • Allan Tsung, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 10^9/L, Platelet count ≥ 100 x 10^9/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 history of another anti-tumor therapy including chemotherapy, radiation, and/or surgery for pancreatic cancer
  • 8. A cardiovascular condition at the time of the screening visit that deems trial participation inappropriate due to one or more of the following: ① Class III or IV heart failure according to New York Heart Association (NYHA) classification, ② Acute coronary syndrome (unstable angina or myocardial infarction) within the last 24 weeks, ③ Uncontrolled heart arrhythmia, ④ 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: ① Other uncontrolled chronic infectious diseases, ② Active autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, ulcerative colitis, Crohn's disease, multiple sclerosis, ankylosing spondylitis, etc.), ③ Congenital or acquired immunodeficiency diseases, such as cellular immunodeficiency, hypogammaglobulinemia, and hypergammaglobulinemia., ④ Clinically significant mental illness
  • 10. Known history of malignancies other than pancreatic cancer within the last 2 years, except for adequately treated basal cell or squamous cell skin cancer or carcinoma in situ (e.g., breast, cervix)
  • 11. Known history of major surgery within 4 weeks of the cycle 1 day 1 (C1D1)
  • 12. Pregnant and breastfeeding women
  • 13. Trial 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
The experimental group receives chemotherapy regimen [irinotecan hydrochloride, oxaliplatin, fluorouracil (5-FU) and leucovorin] in combination with IMD10.
Device: IMD10
A non-thermal/non-tissue destructive Focused Ultrasound (FUS) device
Drug: chemotherapy regimen [irinotecan hydrochloride, oxaliplatin, fluorouracil (5-FU) and leucovorin]
Chemotherapy regimen consisting of irinotecan hydrochloride, oxaliplatin, fluorouracil (5-FU) and leucovorin
Active Comparator: Control group
The control group receives a chemotherapy regimen [irinotecan hydrochloride, oxaliplatin, fluorouracil (5-FU) and leucovorin] alone, the same regimen administered to the experimental group.
Drug: chemotherapy regimen [irinotecan hydrochloride, oxaliplatin, fluorouracil (5-FU) and leucovorin]
Chemotherapy regimen consisting of irinotecan hydrochloride, oxaliplatin, fluorouracil (5-FU) and leucovorin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: From the date of the first trial participant's randomization to 24 months after the last trial participant's randomization
From the date of the first trial participant's randomization to 24 months after the last trial participant's randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IMGT Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

August 1, 2029

Study Completion (Estimated)

August 1, 2029

Study Registration Dates

First Submitted

January 6, 2026

First Submitted That Met QC Criteria

January 6, 2026

First Posted (Estimated)

January 8, 2026

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

January 8, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMG-D01-31

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pancreatic Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tanzania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe