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.
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.
1. The presence of a cystic lesion within tumor to be treated, or at the pancreas adjacent to the treated tumor.
2. Extensive scars or surgical clips observed in the region through which the ultrasound beam will pass
3. Targeted tumor(s) is not clearly visible with IMD10.
4. Tumor is not treatable by the working range of IMD10
Parallel
IMD10
DeviceA non-thermal/non-tissue destructive Focused Ultrasound (FUS) device
chemotherapy regimen [irinotecan hydrochloride, oxaliplatin, fluorouracil (5-FU) and leucovorin]
DrugChemotherapy regimen consisting of irinotecan hydrochloride, oxaliplatin, fluorouracil (5-FU) and leucovorin
Overall Survival
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This trial is not recruiting at the moment. You can still explore other options:
