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A Phase II Study by Using CICS-1 and SPM-011 Commissioned by CICS and STELLA PHARMA | Clinical Trials | Clareo Health

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A Phase II Study by Using CICS-1 and SPM-011 Commissioned by CICS and STELLA PHARMA

A Phase II Study of Boron Neutron Capture Therapy (BNCT) for Patients With Unresectable Angiosarcoma, by Using CICS-1 and SPM-011

NCT05601232•Stella Pharma Corporation

View on ClinicalTrials.gov

Summary

The purpose of the study is to investigate efficacy and safety Boron Neutron Capture Therapy (BNCT) by using CICS-1 accelerator-based neutron capture therapy device with lithium targets developed by CICS, and the SPM-011 boron compound for use in BNCT developed by STELLA PHARMA in the treatment of unresectable angiosarcoma.

Eligibility

Age

18 - 89 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Written informed consent must be obtained from the subject.
•Histologically documented primary skin angiosarcoma.

Exclusion Criteria

•Measurable disease, as defined by RECIST v1.1.
•The longest diameter of the entire target lesion is 15 cm or less.
•ECOG performance status score of Grade 0 to 2
•Apparent disseminated tumor lesions.
•Hereditary fructose intolerance.
•Phenylketonuria.
•Any serious concomitant disease that precludes completion of the study treatment.
•The target lesion has received radiation exceeding 75 Gy.

Locations (1)

National Cancer Center Hospital

Tokyo, Japan

Key Dates

Start Date

November 1, 2022

Primary Completion Date

November 30, 2024

Completion Date

August 31, 2025

Last Updated

April 9, 2025

Enrollment

ESTIMATED participants

Conditions

Unresectable Angiosarcoma

Interventions

BNCT

RADIATION