A prospective, single-center, randomized, controlled, evaluator-blinded(independent evaluator), feasibility clinical trial to evaluate efficacy and safety of Pulsed High-Intensity Focused Ultrasound therapy ‘IMD10’ with neoadjuvant in pancreatic cancer

Not Applicable

• Conditions: Neoplasms

• Registration Number: KCT0008066
• Lead Sponsor: IMGT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 10 January 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 30

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
?Persons judged as clinically significant cardiovascular abnormalities by investigators
8.At the time of screening, a person who has or has a history of one or more of the following diseases
?Other uncontrolled chronic infectious diseases
?Active autoimmune diseases (ex, rheumatoid arthritis, systemic lupus erythematosus, ulcerative colitis, Crohn's disease, multiple sclerosis, ankylosing spondylitis, etc.)
?Congenital or acquired immunodeficiency diseases such as cell immunodeficiency syndrome, hypogammaglobulinemia, and dysgammaglobulinemia
?Clinically significant mental illness
?Patients with a history of malignant tumors other than pancreatic cancer within the past 5 years (However, patients with a history of basal cell or squamous cell skin cancer and non-invasive carcinomas can participate in clinical trial only if properly treated)
?A history of major surgery within 4 weeks at the time of screening
9.Who have difficulty communicating
10.Who are pregnant or breastfeeding
11.Who is currently participating in or has participated in clinical trials of other investigational products/investigational devices within 90 days at the time of screening
12.etc, When the investigator determines that participation in the clinical trial is inappropriate because it may affect the clinical trial results or ethically
? The specific reason shall be write in the case report form

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
target lesion size change ratio

Secondary Outcome Measures

Name	Time	Method
Tumor response;Proportion of subjects identified as complete response (CR) or partial response (PR) in target lesions (N%);The amount of change in carbohydrate antigen 19-9 (CA19-9) (U/ml);Conversion surgery ratio (%);Overall survival