About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- IMD10
- chemotherapy regimen [irinotecan hydrochloride, oxaliplatin, fluorouracil (5-FU) and leucovorin]