Clinical trial NCT05601323: A Study of Suizenji in Patients With Unresectable Pancreatic Cancer
Official title: A Randomized Controlled Study of Suizenji in Patients With Unresectable Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Unresectable Pancreatic Cancer
Keywords: Unresectable Pancreatic Cancer
Suizenji
high intensity focused ultrasound
HIFU
Lead sponsor: SONIRE Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2022-11-01
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: Overall Survival
timeFrame: Up to approximately 24 months
Secondary outcomes:
measure: Progression-free survival
timeFrame: Up to approximately 12 months
measure: 1-year survival rate
timeFrame: Up to approximately 12 months
measure: Objective response rate
timeFrame: Up to approximately 12 months
measure: Disease control rate
timeFrame: Up to approximately 12 months
measure: Adverse Events
timeFrame: Up to approximately 12 months
Other outcomes:
Locations:
city: Nagakute-shi, Aichi
country: Japan
facility: Aichi Medical University Hospital
city: Sendai-shi, Miyagi
country: Japan
facility: Tohoku University Hospital
city: Shinjuku-ku, Tokyo
country: Japan
facility: Tokyo Medical University Hospita
city: Toyama-shi, Toyama
country: Japan
facility: Toyama University Hospital
city: Wakayama-shi, Wakayama
country: Japan
facility: Wakayama Medical University Hospital
city: Yokohama-shi, Kanagawa
country: Japan
facility: Yokohama City University Medical Center
city: Yokohama-shi, Kanagawa
country: Japan
facility: Kanagawa Cancer Center
Study officials:
affiliation: SONIRE Therapeutics Inc.
name: SONIRE Therapeutics Inc.
role: STUDY_DIRECTOR
References: