NCT05601323Active, not recruiting
A Study of Suizenji in Patients With Unresectable Pancreatic Cancer
A Randomized Controlled Study of Suizenji in Patients With Unresectable Pancreatic Cancer
Source: ClinicalTrials.gov · Last updated 16 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 27 Oct 2022
- Start date
- 31 Jan 2023
- Primary completion date
- 31 May 2027
- Lead sponsor
- SONIRE Therapeutics Inc.
- Diseases
- Pancreatic cancer
- NCT number
- NCT05601323
What you commit to
- Study type: Interventional
- Planned participants: 90
- From 31 Jan 2023 to the primary completion date, 31 May 2027
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindications to the use of secondary chemotherapy used in this study.
Other illness
- Active multiple cancers that require treatment.
- Child-Pugh Classification B or C liver failure due to liver metastases.
- Cystic component within the pancreatic cancer.
Other
- 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.
- Tumor embolization in the veins surrounding the pancreas.
- Peritoneal dissemination.
- Pleural effusion or ascites with poorly controlled
Who the study is looking for
- 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.
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aichi Medical University Hospital Coordinator of this site? Confirm its status | Nagakute-shi, Aichi | Japan | Unknown status |
| Tohoku University Hospital Coordinator of this site? Confirm its status | Sendai-shi, Miyagi | Japan | Unknown status |
| Tokyo Medical University Hospita Coordinator of this site? Confirm its status | Shinjuku-ku, Tokyo | Japan | Unknown status |
| Toyama University Hospital Coordinator of this site? Confirm its status | Toyama-shi, Toyama | Japan | Unknown status |
| Wakayama Medical University Hospital Coordinator of this site? Confirm its status | Wakayama-shi, Wakayama | Japan | Unknown status |
| Yokohama City University Medical Center Coordinator of this site? Confirm its status | Yokohama-shi, Kanagawa | Japan | Unknown status |
| Kanagawa Cancer Center Coordinator of this site? Confirm its status | Yokohama-shi, Kanagawa | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.