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Trial record 1 of 1 for:    NCT05601323
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A Study of Suizenji in Patients With Unresectable Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT05601323
Recruitment Status : Recruiting
First Posted : November 1, 2022
Last Update Posted : February 2, 2023
Sponsor:
Information provided by (Responsible Party):
SONIRE Therapeutics Inc.

Study Description
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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
Unresectable Pancreatic Cancer Device: Suizenji Drug: Nal-IRI/FL Drug: mFOLFIRINOX Drug: Gem/nab-PTX Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 31, 2023
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Overall Survival [ Time Frame: Up to approximately 24 months ]

Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: Up to approximately 12 months ]
  2. 1-year survival rate [ Time Frame: Up to approximately 12 months ]
  3. Objective response rate [ Time Frame: Up to approximately 12 months ]
  4. Disease control rate [ Time Frame: Up to approximately 12 months ]
  5. Adverse Events [ Time Frame: Up to approximately 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05601323


Contacts
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Contact: SONIRE Therapeutics Inc. +81-50-3733-1000 info@sonire-t.com

Locations
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Japan
Tohoku University Hospital Not yet recruiting
Sendai-shi, Miyagi, Japan, 980-8574
Tokyo Medical University Hospita Recruiting
Shinjuku-ku, Tokyo, Japan, 160-0023
Yokohama City University Medical Center Not yet recruiting
Yokohama-shi, Kanagawa, Japan, 232-0024
Sponsors and Collaborators
SONIRE Therapeutics Inc.
Investigators
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Study Director: SONIRE Therapeutics Inc. SONIRE Therapeutics Inc.
More Information
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Responsible Party: SONIRE Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT05601323    
Other Study ID Numbers: Sonire-PAC-001
First Posted: November 1, 2022    Key Record Dates
Last Update Posted: February 2, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by SONIRE Therapeutics Inc.:
Unresectable Pancreatic Cancer
Suizenji
high intensity focused ultrasound
HIFU
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases