NCT07325214

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 136 (estimated)
• Sponsor: IMGT Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-04-01
• Primary completion: 2029-08-01
• Completion: 2029-08-01
• First posted: 2026-01-08
• Last updated: 2026-01-12

Locations

5 sites across 2 countries: United States, South Korea

Regulatory

• FDA-regulated device study