Overview
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
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. (Including cases where the individual refuses treatment.)
- 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
Exclusion Criteria:
- 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.