A Study of Suizenji in Patients With Unresectable Pancreatic Cancer

Sponsor
SONIRE Therapeutics Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05601323
Collaborator
(none)
90
3
2
23
30
1.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Controlled Study of Suizenji in Patients With Unresectable Pancreatic Cancer
Actual Study Start Date :
Jan 31, 2023
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: HIFU (High-Intensity Focused Ultrasound) + Chemotherapy

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
HIFU treatment

Drug: Nal-IRI/FL
Nanoliposomal irinotecan, Fluorouracil, Levofolinate

Drug: mFOLFIRINOX
Fluorouracil, Levofolinate, Irinotecan, Oxaliplatin

Drug: Gem/nab-PTX
Gemcitabine, nab-Paclitaxel

Active Comparator: Chemotherapy

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

Drug: Nal-IRI/FL
Nanoliposomal irinotecan, Fluorouracil, Levofolinate

Drug: mFOLFIRINOX
Fluorouracil, Levofolinate, Irinotecan, Oxaliplatin

Drug: Gem/nab-PTX
Gemcitabine, nab-Paclitaxel

Outcome Measures

Primary Outcome Measures

  1. Overall Survival [Up to approximately 24 months]

Secondary Outcome Measures

  1. Progression-free survival [Up to approximately 12 months]

  2. 1-year survival rate [Up to approximately 12 months]

  3. Objective response rate [Up to approximately 12 months]

  4. Disease control rate [Up to approximately 12 months]

  5. Adverse Events [Up to approximately 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tohoku University Hospital Sendai-shi, Miyagi Japan 980-8574
2 Tokyo Medical University Hospita Shinjuku-ku, Tokyo Japan 160-0023
3 Yokohama City University Medical Center Yokohama-shi, Kanagawa Japan 232-0024

Sponsors and Collaborators

  • SONIRE Therapeutics Inc.

Investigators

  • Study Director: SONIRE Therapeutics Inc., SONIRE Therapeutics Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
SONIRE Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT05601323
Other Study ID Numbers:
  • Sonire-PAC-001
First Posted:
Nov 1, 2022
Last Update Posted:
Feb 2, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by SONIRE Therapeutics Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 2, 2023