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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031220410

Enrollment

Registered

2022-10-26

Start date

2023-01-19

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unresectable angiosarcoma

Interventions

SPM-011 (JAN:Borofalan (10B)) is administered intravenously at a rate of 200 mg/kg per hour for 2 hours. The irradiation of the target lesion with neutron beams is then initiated, and SPM-011 is admin

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Response rate (RECIST v1.1)	—

Contacts

Public ContactClinical trials information

Stella Pharma Corporation

sp-chiken@stella-pharma.co.jp+81-6-4707-1516

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026