A Study of Suizenji in Patients With Unresectable Pancreatic Cancer

Not Applicable

Recruiting

• Conditions: Unresectable Pancreatic Cancer
• Interventions: Drug: Nal-IRI/FL; Device: Suizenji; Drug: mFOLFIRINOX; Drug: Gem/nab-PTX

• Registration Number: NCT05601323
• Lead Sponsor: SONIRE Therapeutics Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-27
• Study First Submitted QC: 2022-10-27
• Study First Posted: 2022-11-01
• Study Start: 2023-01-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-06
• Primary Completion: 2026-09-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chemotherapy	Nal-IRI/FL	Chemotherapy (physician's choice): Nal-IRI/FL, mFOLFIRINOX or Gem/nab-PTX
Chemotherapy	mFOLFIRINOX	Chemotherapy (physician's choice): Nal-IRI/FL, mFOLFIRINOX or Gem/nab-PTX
Chemotherapy	Gem/nab-PTX	Chemotherapy (physician's choice): Nal-IRI/FL, mFOLFIRINOX or Gem/nab-PTX
HIFU (High-Intensity Focused Ultrasound) + Chemotherapy	Nal-IRI/FL	HIFU treatment with Suizenji: up to 2 times per week (1 course) for pancreatic primary lesions; the second course should be at least 60 days apart, up to a maximum of 5 courses. Chemotherapy (physician's choice): Nal-IRI/FL, mFOLFIRINOX or Gem/nab-PTX
HIFU (High-Intensity Focused Ultrasound) + Chemotherapy	mFOLFIRINOX	HIFU treatment with Suizenji: up to 2 times per week (1 course) for pancreatic primary lesions; the second course should be at least 60 days apart, up to a maximum of 5 courses. Chemotherapy (physician's choice): Nal-IRI/FL, mFOLFIRINOX or Gem/nab-PTX
HIFU (High-Intensity Focused Ultrasound) + Chemotherapy	Gem/nab-PTX	HIFU treatment with Suizenji: up to 2 times per week (1 course) for pancreatic primary lesions; the second course should be at least 60 days apart, up to a maximum of 5 courses. Chemotherapy (physician's choice): Nal-IRI/FL, mFOLFIRINOX or Gem/nab-PTX
HIFU (High-Intensity Focused Ultrasound) + Chemotherapy	Suizenji	HIFU treatment with Suizenji: up to 2 times per week (1 course) for pancreatic primary lesions; the second course should be at least 60 days apart, up to a maximum of 5 courses. Chemotherapy (physician's choice): Nal-IRI/FL, mFOLFIRINOX or Gem/nab-PTX

Primary Outcome Measures

Name	Time	Method
Overall Survival	Up to approximately 24 months

Secondary Outcome Measures

Name	Time	Method
Disease control rate	Up to approximately 12 months
Objective response rate	Up to approximately 12 months
Adverse Events	Up to approximately 12 months
Progression-free survival	Up to approximately 12 months
1-year survival rate	Up to approximately 12 months

Trial Locations

Locations (7)

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

Wakayama Medical University Hospital; 🇯🇵 Wakayama-shi, Wakayama, Japan

Yokohama City University Medical Center; 🇯🇵 Yokohama-shi, Kanagawa, Japan

Kanagawa Cancer Center; 🇯🇵 Yokohama-shi, Kanagawa, Japan