臨床研究等提出・公開システム

Japanese

Date of registration	July. 31, 2024
Last modified on	July. 31, 2024
Trial ID	jRCT2031240246

Scientific Title	Phase I/II basket trial: Boron Neutron Capture Therapy (BNCT) using CICS-1 and SPM-011 for patients with recurrent solid malignant thoracic tumors that are unresectable and perceived challenging to treat with standard treatment (SJ-BT001)
Public Title	Phase I/II basket trial: Boron Neutron Capture Therapy (BNCT) using CICS-1 and SPM-011 for patients with recurrent solid malignant thoracic tumors that are unresectable and perceived challenging to treat with standard treatment

Contact for Scientific Queries	Name	Hayashi Toshimitsu
	Affiliation	STELLA PHARMA CORPORATION
	Address	ORIX Kouraibashi Building, 3-2-7 Kouraibashi, Chuo-ku, Osaka
	Telephone	+81-6-4707-1516
	E-mail	sp-chiken@stella-pharma.co.jp
Contact for Public Queries	Name	Clinical trials information
	Affiliation	Stella Pharma Corporation
	Address	ORIX Kouraibashi Building, 3-2-7 Kouraibashi, Chuo-ku, Osaka
	Telephone	+81-647071516
	E-mail	sp-chiken@stella-pharma.co.jp

Recruitment status	Pending

Anticipated date of first enrollment		July. 31, 2024
Actual date of first enrollment
Target sample size		30
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	- Written informed consent must be obtained from the subject. - Patients with histopathological diagnosed malignant tumor (except cutaneous angiosarcoma) - Measurable disease, as defined by RECIST v1.1. - Patients diagnosed with recurrent malignant tumors that are unresectable and perceived challenging to treat with standard treatment. - Patients with ECOG performance status score of 0 or 1. - Patients whose longest diameter sum of the lesions to be treated is 15 cm or less.
	Exclusion Criteria	- Patients with active disease or active double cancers other than target lesions. - Patients with imaging findings that affect imaging evaluation of the tumor, such as ground-glass opacities - Patients who received radiation therapy exceeding 65 Gy as a prior treatment for the target lesion. - Any serious concomitant disease that precludes completion of the study treatment. - Patients with remaining complications of Grade 3 or higher related to prior radiation therapy in the irradiation field.
	Age Minimum	18age old over
	Age Maximum	85age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Thoracic solid malignant tumor
Intervention(s)		- Intravenous administration of investigational drug. 1st time/2nd time - Neutron irradiation of the clinical target volume with the investigational device. 1st time /2nd time - Intravenous injection of 18F-FBPA and radiation exposure from PET-CT scan.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		- Occurrence rate of dose-limiting toxicity - Response rate (RECIST v1.1)
Secondary Outcome(s)

Primary Sponsor	Stella Pharma Corporation

Primary Sponsor	Cancer Intelligence Care Systems, Inc.

Primary Sponsor	Sumitomo Heavy Industries, Ltd.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	National Cancer Center Institutional Review Board
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo, Tokyo, Tokyo
Telephone	+81-3-3542-2511
E-Mail	Chiken_CT@ml.res.ncc.go.jp
Approval Status
Date of approval

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none