Evaluating Suizenji for Patients with Unresectable Pancreatic Cancer

A Randomized Controlled Study of Suizenji in Patients With Unresectable Pancreatic Cancer

This study is testing if adding a new ultrasound treatment called Suizenji to regular chemotherapy can help people with pancreatic cancer that can't be surgically removed and haven't responded to other treatments.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 20 Years and up
• Sex: All
• Sponsor: SONIRE Therapeutics Inc. (industry)
• Drugs / interventions: chemotherapy
• Locations: 7 sites (Nagakute-shi, Aichi and 6 other locations)
• Trial ID: NCT05601323 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and effectiveness of combining standard chemotherapy with a novel High Intensity Focused Ultrasound system, known as Suizenji, in patients suffering from unresectable pancreatic cancer who have not responded to or cannot tolerate first-line chemotherapy. Participants will receive either the standard chemotherapy regimens or the combination with Suizenji, with the goal of improving treatment outcomes. The study will focus on patients whose tumors can be visualized and treated using ultrasound echography.

Who should consider this trial

Good fit: Ideal candidates include adults aged 20 and over with unresectable pancreatic cancer who have not responded to first-line chemotherapy and have measurable lesions.

Not a fit: Patients with active multiple cancers, significant liver failure, or those with certain tumor characteristics may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new treatment option for patients with limited choices due to refractory or intolerant responses to existing therapies.

How similar studies have performed: While the use of High Intensity Focused Ultrasound in cancer treatment is gaining interest, this specific combination with chemotherapy in pancreatic cancer is relatively novel and has not been extensively tested in prior studies.

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.

Where this trial is running

Nagakute-shi, Aichi and 6 other locations

• Aichi Medical University Hospital — Nagakute-shi, Aichi, Japan (RECRUITING)
• Tohoku University Hospital — Sendai-shi, Miyagi, Japan (RECRUITING)
• Tokyo Medical University Hospita — Shinjuku-ku, Tokyo, Japan (RECRUITING)
• Toyama University Hospital — Toyama-shi, Toyama, Japan (RECRUITING)
• Wakayama Medical University Hospital — Wakayama-shi, Wakayama, Japan (RECRUITING)
• Yokohama City University Medical Center — Yokohama-shi, Kanagawa, Japan (RECRUITING)
• Kanagawa Cancer Center — Yokohama-shi, Kanagawa, Japan (RECRUITING)

Study contacts

• Study coordinator: SONIRE Therapeutics Inc.

Conditions: Unresectable Pancreatic Cancer, Suizenji, high intensity focused ultrasound, HIFU