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
IMGT Co., Ltd.
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.
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 wil…
Eligibility
- Age range
- 18–85 years
- Sex
- All
- Healthy volunteers
- No
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\. Th…
Interventions
- DeviceIMD10
A non-thermal/non-tissue destructive Focused Ultrasound (FUS) device
- Drugchemotherapy regimen [irinotecan hydrochloride, oxaliplatin, fluorouracil (5-FU) and leucovorin]
Chemotherapy regimen consisting of irinotecan hydrochloride, oxaliplatin, fluorouracil (5-FU) and leucovorin
Locations (5)
- Brigham and Women's HospitalBoston, Massachusetts
- University of Texas Health Science Center at San AntonioSan Antonio, Texas
- University of Virginia Medical CenterCharlottesville, Virginia
- Seoul National University Bundang Hospital,Gyeonggi-do
- Seoul National University HospitalSeoul