KCT0008066
Not yet recruiting
未知
A prospective, single-center, randomized, controlled, evaluator-blinded, feasibility clinical trial to evaluate efficacy and safety of Pulsed High-Intensity Focused Ultrasound therapy ‘IMD10’ with neoadjuvant FOLFIRINOX in locally advanced pancreatic cancer or borderline resectable pancreatic cancer
IMGT0 sites30 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- IMGT
- Enrollment
- 30
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Adults of age \= 19 and \<85
- •2\.A Person diagnosed with pancreatic ductal adenocarcinoma (PDAC) through biopsy
- •3\.Within 4 weeks at the time of screening, who is diagnosed with locally advanced pancreatic cancer (LAPC) or borderline resectable pancreatic cancer (BRPC) by computed tomography (CT) or magnetic resonance imaging (MRI), and who is determined to require neoadjuvant FOLFIRINOX/mFOLFIRINOX regimen.
- •4\.Who have one or more measurable lesions on CT or MRI according by response evaluation criteria in solid tumors (RECIST) version 1\.1 at the time of screening.
- •5\.Persons with karnofsky performance scale (KPS) of 70% or more.
- •6\.A person who agrees to medically permitted contraception\* during the clinical trial period
- •\*Hormonal contraception, intrauterine device, vasectomy, tubal ligation, double blocking method (combined use of blocking methods such as male condom, female condom, cervical cap, diaphragm, and contraceptive sponge), single blocking method using spermicide
- •7\.Who voluntarily decides to participate in this clinical trial and has agreed to the Informed Consent Form in writing.
- •8\.Who are willing to comply with the clinical trial protocol
Exclusion Criteria
- •1\.The presence of a cystic lesion within pancreatic cancer to be treated with high\-intensity focused ultrasound (HIFU) or at the pancreas adjacent to the pancreatic cancer.
- •2\.The presence of a wide range of scar or surgical clips observed in the passage through the ultrasonic beam.
- •3\.In case proper ultrasound image for HIFU procedure is not visible
- •4\.Who are unable to lie down during HIFU application time
- •5\.Who has experienced a toxic or hypersensitivity reaction to FOLFIRINOX chemotherapy (oxaliplatin, irinotecan hydrochloride, calcium folinate, fluorouracil)
- •6\.Pancreatic cancer patients who have previously been anti\-cancer treatment
- •7\.At the time of screening, a person who is unsuitable for a clinical trial, because of one or more of the following cardiovascular diseases,
- •?Class III or IV heart failure by classification of the New York Heart Association (NYHA)
- •?Acute coronary syndrome (unstable angina or myocardial infarction) occurring within the last 6 months
- •?Uncontrolled cardiac arrhythmias
Outcomes
Primary Outcomes
Not specified
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