To hear about similar clinical trials, please enter your email below
Trial Title:
A Study of Suizenji in Patients With Unresectable Pancreatic Cancer
NCT ID:
NCT05601323
Condition:
Unresectable Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Conditions: Keywords:
Unresectable Pancreatic Cancer
Suizenji
high intensity focused ultrasound
HIFU
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Suizenji
Description:
HIFU treatment
Arm group label:
HIFU (High-Intensity Focused Ultrasound) + Chemotherapy
Intervention type:
Drug
Intervention name:
Nal-IRI/FL
Description:
Nanoliposomal irinotecan, Fluorouracil, Levofolinate
Arm group label:
Chemotherapy
Arm group label:
HIFU (High-Intensity Focused Ultrasound) + Chemotherapy
Intervention type:
Drug
Intervention name:
mFOLFIRINOX
Description:
Fluorouracil, Levofolinate, Irinotecan, Oxaliplatin
Arm group label:
Chemotherapy
Arm group label:
HIFU (High-Intensity Focused Ultrasound) + Chemotherapy
Intervention type:
Drug
Intervention name:
Gem/nab-PTX
Description:
Gemcitabine, nab-Paclitaxel
Arm group label:
Chemotherapy
Arm group label:
HIFU (High-Intensity Focused Ultrasound) + Chemotherapy
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Ages 20 years and over.
- Unresectable pancreatic cancer (including metastatic pancreatic cancer) who are
refractory or intolerant to first-line chemotherapy. Any first-line chemotherapy is
acceptable.
- Target treatment tumor is located in the pancreas, and the target tumor can be
visualized with ultrasound echography and can also be treated by high-intensity
focused ultrasound.
- Has primary tumor site of measurable lesion according to RECIST guidelines version
1.1
- ECOG performance status of 0 to 2.
Exclusion Criteria:
- Active multiple cancers that require treatment.
- Suspected gastrointestinal invasion of the primary tumor based on CT scan.
- Obstructive jaundice. However, patients who have a bile duct stent placed for
obstructive jaundice by the time of allocation may be enrolled.
- Child-Pugh Classification B or C liver failure due to liver metastases.
- Tumor embolization in the veins surrounding the pancreas.
- Cystic component within the pancreatic cancer.
- Peritoneal dissemination.
- Pleural effusion or ascites with poorly controlled
- Contraindications to the use of secondary chemotherapy used in this study.
Gender:
All
Minimum age:
20 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Tohoku University Hospital
Address:
City:
Sendai-shi, Miyagi
Zip:
980-8574
Country:
Japan
Status:
Recruiting
Facility:
Name:
Tokyo Medical University Hospita
Address:
City:
Shinjuku-ku, Tokyo
Zip:
160-0023
Country:
Japan
Status:
Recruiting
Facility:
Name:
Toyama University Hospital
Address:
City:
Toyama-shi, Toyama
Zip:
930-0194
Country:
Japan
Status:
Recruiting
Facility:
Name:
Wakayama Medical University Hospital
Address:
City:
Wakayama-shi, Wakayama
Zip:
641-8510
Country:
Japan
Status:
Recruiting
Facility:
Name:
Yokohama City University Medical Center
Address:
City:
Yokohama-shi, Kanagawa
Zip:
232-0024
Country:
Japan
Status:
Recruiting
Facility:
Name:
Kanagawa Cancer Center
Address:
City:
Yokohama-shi, Kanagawa
Zip:
241-8515
Country:
Japan
Status:
Recruiting
Start date:
January 31, 2023
Completion date:
October 31, 2025
Lead sponsor:
Agency:
SONIRE Therapeutics Inc.
Agency class:
Industry
Source:
SONIRE Therapeutics Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05601323
