A Study of Suizenji in Patients With Unresectable Pancreatic Cancer

NCT05601323 | Active Not Recruiting

• 1 other identifier: Sonire-PAC-001
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 7

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.

Conditions

Unresectable Pancreatic Cancer

Keywords

Unresectable Pancreatic Cancer; Suizenji; high intensity focused ultrasound; HIFU

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Up to approximately 24 months

Secondary Outcomes (5)

• Progression-free survival

  Up to approximately 12 months

• 1-year survival rate

  Up to approximately 12 months

• Objective response rate

  Up to approximately 12 months

• Disease control rate

  Up to approximately 12 months

• Adverse Events

  Up to approximately 12 months

Study Arms (2)

HIFU (High-Intensity Focused Ultrasound) + Chemotherapy

EXPERIMENTAL

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

Device: Suizenji; Drug: Nal-IRI/FL; Drug: mFOLFIRINOX; Drug: Gem/nab-PTX

Chemotherapy

ACTIVE COMPARATOR

Chemotherapy (physician's choice): Nal-IRI/FL, mFOLFIRINOX or Gem/nab-PTX

Drug: Nal-IRI/FL; Drug: mFOLFIRINOX; Drug: Gem/nab-PTX

Interventions

Suizenji DEVICE

HIFU treatment

HIFU (High-Intensity Focused Ultrasound) + Chemotherapy

Nal-IRI/FL DRUG

Nanoliposomal irinotecan, Fluorouracil, Levofolinate

Chemotherapy; HIFU (High-Intensity Focused Ultrasound) + Chemotherapy

mFOLFIRINOX DRUG

Fluorouracil, Levofolinate, Irinotecan, Oxaliplatin

Chemotherapy; HIFU (High-Intensity Focused Ultrasound) + Chemotherapy

Gem/nab-PTX DRUG

Gemcitabine, nab-Paclitaxel

Chemotherapy; HIFU (High-Intensity Focused Ultrasound) + Chemotherapy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SONIRE Therapeutics Inc.: lead

Study Sites (7)

Aichi Medical University Hospital

Nagakute-shi, Aichi, 480-1195, Japan

Location

Tohoku University Hospital

Sendai-shi, Miyagi, 980-8574, Japan

Location

Tokyo Medical University Hospita

Shinjuku-ku, Tokyo, 160-0023, Japan

Location

Toyama University Hospital

Toyama-shi, Toyama, 930-0194, Japan

Location

Wakayama Medical University Hospital

Wakayama-shi, Wakayama, 641-8510, Japan

Location

Yokohama City University Medical Center

Yokohama-shi, Kanagawa, 232-0024, Japan

Location

Kanagawa Cancer Center

Yokohama-shi, Kanagawa, 241-8515, Japan

Location

Study Officials

• SONIRE Therapeutics Inc.

  SONIRE Therapeutics Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: November 1, 2022
• Study Start: January 31, 2023
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: March 16, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (7)