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

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.

Inclusion Criteria:Written informed consent must be obtained from the subject.Histologically documented primary skin angiosarcoma.Locally advanced or locally recurrent angiosarcoma, and not eligible for curative surgery, chemoradiotherapy or radiotherapy.Measurable disease, as defined by RECIST v1.1.Exclusion Criteria:Apparent disseminated tumor lesions.Hereditary fructose intolerance.Phenylketonuria.Any serious concomitant disease that precludes completion of the study treatment.