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

NCT07325214 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: IMG-D01-31
• Study Type: interventional
• Target: 136
• Locations: 2 countries
• Sites: 5

Brief 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.

Conditions

Pancreatic Cancer; Borderline Resectable Pancreatic Cancer; Locally Advanced Pancreatic Cancer

Keywords

Focused Ultrasound

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  From the date of the first trial participant's randomization to 24 months after the last trial participant's randomization

Study Arms (2)

Experimental group

EXPERIMENTAL

The experimental group receives chemotherapy regimen \[irinotecan hydrochloride, oxaliplatin, fluorouracil (5-FU) and leucovorin\] in combination with IMD10.

Device: IMD10; Drug: chemotherapy regimen [irinotecan hydrochloride, oxaliplatin, fluorouracil (5-FU) and leucovorin]

Control group

ACTIVE COMPARATOR

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]

Interventions

chemotherapy regimen [irinotecan hydrochloride, oxaliplatin, fluorouracil (5-FU) and leucovorin] DRUG

Chemotherapy regimen consisting of irinotecan hydrochloride, oxaliplatin, fluorouracil (5-FU) and leucovorin

Control group; Experimental group

IMD10 DEVICE

A non-thermal/non-tissue destructive Focused Ultrasound (FUS) device

Experimental group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• An individual must meet all the following criteria:
• \. Willing and able to understand and sign an ICF and to comply with all aspects of the protocol
• \. Aged between 18 and 85 years, inclusive
• \. Histologically or cytologically, pathologically confirmed diagnosis of PDAC.
• \. 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
• \. Must have at least 1 measurable lesion per RECIST 1.1 criteria at the screening visit.
• \. The ECOG performance status 0 or 1
• \. 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
• \. Life expectancy is more than 12 weeks
• \. 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
• \. 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:
• \. The presence of a cystic lesion within tumor to be treated, or at the pancreas adjacent to the treated tumor.
• \. Extensive scars or surgical clips observed in the region through which the ultrasound beam will pass
• \. Targeted tumor(s) is not clearly visible with IMD10.
• \. Tumor is not treatable by the working range of IMD10
• \. Patient has difficulty in lying in supine position
• \. Known history of severe hypersensitivity to ultrasound gel or to chemotherapies (irinotecan hydrochloride, oxaliplatin, fluorouracil (5-FU) and leucovorin) used in this clinical trial
• \. Known history of another anti-tumor therapy including chemotherapy, radiation, and/or surgery for pancreatic cancer
• \. 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
• \. 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
• \. 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)
• \. Known history of major surgery within 4 weeks of the cycle 1 day 1 (C1D1)
• \. Pregnant and breastfeeding women
• \. Trial participating in another drug/device clinical trial or have participated in another drug/device clinical trial within 4 weeks of C1D1
• \. 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

Sponsors & Collaborators

• IMGT Co., Ltd.: lead

Study Sites (5)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

University of Virginia Medical Center

Charlottesville, Virginia, 22908, United States

Location

Seoul National University Bundang Hospital,

Gyeonggi-do, 13620, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Drug Therapy; Irinotecan; Oxaliplatin; Fluorouracil; Leucovorin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Camptothecin; Alkaloids; Heterocyclic Compounds; Coordination Complexes; Organic Chemicals; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Central Study Contacts

Jeongmin Jang, Clinical Team

CONTACT

+82-70-5080-2438; jeongmin.jang@nanoimgt.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This clinical trial will be conducted as an open-label study for both investigators and trial participants. Blinding will be applied only to the independent tumor response evaluator(s) responsible for tumor response assessment of pancreatic adenocarcinoma based on the anonymized CT (or MRI) images that have been uploaded to the central imaging center.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 8, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: January 12, 2026

Record last verified: 2026-01

Locations

KR (2); US (3)