A Study of Suizenji in Patients With Unresectable Pancreatic Cancer

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Description

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.

Study Overview

Start Date
January 31, 2023
Completion Date
October 31, 2025
Enrollment
90
Date Posted
November 1, 2022
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
Tohoku University Hospital
Sendai-shi, Miyagi 980-8574, Japan

Tokyo Medical University Hospita
Shinjuku-ku, Tokyo 160-0023, Japan

Wakayama Medical University Hospital
Wakayama-shi, Wakayama 641-8510, Japan

Yokohama City University Medical Center
Yokohama-shi, Kanagawa 232-0024, Japan

Kanagawa Cancer Center
Yokohama-shi, Kanagawa 241-8515, Japan

Eligibility

Minimum Age (years)
20
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.

Study Contact Info

Study Contact Name
SONIRE Therapeutics Inc.
Study Contact Email
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
NCTid (if applicable)
NCT05601323