Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: testing chemotherapy regimen [irinotecan hydrochloride, oxaliplatin, fluorouracil (5-FU) and leucovorin] for Pancreatic Cancer

The purpose of this treatment clinical trial is to evaluate safety and how well it works of 'IMD10 (focused ultrasound)' in the treatment of borderline resectable pancreatic cancer or locally advanced pancreatic cancer.

Official registry: https://clinicaltrials.gov/study/NCT07325214 · IMGT Co., Ltd. · enrollment listed as 366

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are IMD10, or chemotherapy regimen [irinotecan hydrochloride, oxaliplatin, fluorouracil (5-FU) and leucovorin]. The registry lists allocation as randomized. The purpose of this treatment clinical trial is to evaluate safety and how well it works of 'IMD10 (focused ultrasound)' in the treatment of borderline resectable pancreatic cancer or locally advanced pancreatic cancer.

They plan to enroll about 366 people at 5 sites. Taking part typically means taking a study drug (or dummy pill), using or being fitted with a device plus check-ins.

Official title (unrewritten)

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

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

Primary outcome (registry wording): Overall Survival

Who it is for (from inclusion criteria)

  • Ages 18 Years to 85 Years
  • An individual must meet all the following criteria:
  • 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 how well you can do daily activities (ECOG score) 0 or 1
  • 7\. Trial participant having laboratory values defined as:

Public study contact (from the registry)

Jeongmin Jang

+82-70-5080-2438

jeongmin.jang@nanoimgt.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

5 listed

+ 2 sites outside the US on the same record

Related recruiting trials in this snapshot

RecruitingPhase 2Bethesda, Maryland
Phase 2: testing Pembrolizumab (Keytruda) for Metastatic Colorectal Cancer

Background: The NCI Surgery Branch has developed an experimental therapy that involves taking white blood cells from patients' tumors, growing them in the laboratory in large numbers, and then giving the cells back to the patient. These cells are called Tumor Infiltrating Lymphocytes, or TIL and we have given this type of treatment to over 200 patients with melanoma.

NCT01174121 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

FAQ about this NCT record

Is NCT07325214 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07325214?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07325214?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary