The purpose of this study is to evaluate the safety and efficacy of standard chemotherapy with or without a novel High Intensity Focused Ultrasound system (Code: Suizenji) in patients with unresectable pancreatic cancer who are refractory or intolerant to first-line chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
HIFU treatment
Nanoliposomal irinotecan, Fluorouracil, Levofolinate
Fluorouracil, Levofolinate, Irinotecan, Oxaliplatin
Aichi Medical University Hospital
Nagakute-shi, Aichi, Japan
Tohoku University Hospital
Sendai-shi, Miyagi, Japan
Tokyo Medical University Hospita
Shinjuku-ku, Tokyo, Japan
Toyama University Hospital
Toyama-shi, Toyama, Japan
Overall Survival
Time frame: Up to approximately 24 months
Progression-free survival
Time frame: Up to approximately 12 months
1-year survival rate
Time frame: Up to approximately 12 months
Objective response rate
Time frame: Up to approximately 12 months
Disease control rate
Time frame: Up to approximately 12 months
Adverse Events
Time frame: Up to approximately 12 months
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Gemcitabine, nab-Paclitaxel
Wakayama Medical University Hospital
Wakayama-shi, Wakayama, Japan
Yokohama City University Medical Center
Yokohama-shi, Kanagawa, Japan
Kanagawa Cancer Center
Yokohama-shi, Kanagawa, Japan