Chemotherapy With or Without IMD10 (Focused Ultrasound) in the Treatment of Borderline Resectable… (NCT07325214) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Chemotherapy With or Without IMD10 (Focused Ultrasound) in the Treatment of Borderline Resectable or Locally Advanced Pancreatic Cancer
United States, South Korea136 participantsStarted 2026-04
Plain-language 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.
Who can participate
Age range18 Years – 85 Years
SexALL
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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 adja…
What they're measuring
1
Overall Survival
Timeframe: From the date of the first trial participant's randomization to 24 months after the last trial participant's randomization