臨床研究等提出・公開システム

Japanese

Date of registration	Oct. 29, 2022
Last modified on	April. 16, 2024
Trial ID	jRCT2032220428

Scientific Title	A Randomized Controlled Study of Suizenji in Patients with Unresectable Pancreatic Cancer
Public Title	A Randomized Controlled Study of Suizenji in Patients with Unresectable Pancreatic Cancer

Contact for Scientific Queries	Name	Iwasaki Seinori
	Affiliation	SONIRE Therapeutics Inc.
	Address	3-11-5, Nihonbashi-Honcho, Chuo-ku, Tokyo
	Telephone	+81-3-5843-6764
	E-mail	seinori_iwasaki@sonire-t.com
Contact for Public Queries	Name	Iwasaki Seinori
	Affiliation	SONIRE Therapeutics Inc.
	Address	1-23-1, Nishi-Shinjyuku, Shinjyuku-ku, Tokyo
	Telephone	+81-3-5843-6764
	E-mail	seinori_iwasaki@sonire-t.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Oct. 29, 2022
Actual date of first enrollment		Jan. 31, 2023
Target sample size		90
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	(1) Ages 20 years and over. (2) Unresectable pancreatic cancer (including metastatic pancreatic cancer) who are refractory or intolerant to first-line chemotherapy. Any first-line chemotherapy is acceptable. (3) 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. (4) Has primary tumor site of measurable lesion according to RECIST guidelines version 1.1 (5) ECOG performance status of 0 to 2.
	Exclusion Criteria	(1) Active multiple cancers that require treatment. (2) Suspected gastrointestinal invasion of the primary tumor based on CT scan. (3) Obstructive jaundice. However, patients who have a bile duct stent placed for obstructive jaundice by the time of allocation may be enrolled. (4) Child-Pugh Classification B or C liver failure due to liver metastases. (5) Tumor embolization in the veins surrounding the pancreas. (6) Cystic component within the pancreatic cancer. (7) Peritoneal dissemination. (8) Pleural effusion or ascites with poorly controlled (9) Contraindications to the use of secondary chemotherapy used in this study.
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Unresectable pancreatic cancer
Intervention(s)		- HIFU (High-Intensity Focused Ultrasound) + chemotherapy group: 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 - Chemotherapy group: Chemotherapy (physician's choice): Nal-IRI/FL, mFOLFIRINOX or Gem/nab-PTX
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Overall Survival
Secondary Outcome(s)		Progression-free survival (PFS), 1-year survival rate, objective response rate (ORR), disease control rate (DCR), Adverse Events (AEs), etc.

Primary Sponsor	SONIRE Therapeutics Inc.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Tokyo Medical University Hospital Institutional Review Board
Address	6-7-1 Nishishinjuku, Shinjuku-ku,, Tokyo, Tokyo
Telephone	+81-3-3342-6111
E-Mail	adm_crsc@tokyo-med.ac.jp
Approval Status	Approval
Date of approval	Oct. 17, 2022

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	April. 16, 2024	(this page)	Changes
3	Feb. 14, 2024	Detail	Changes
2	Feb. 09, 2023	Detail	Changes
1	Oct. 29, 2022	Detail

List of change history