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

Stella Pharma

Status and phase: Active, not recruiting; Phase 2

Conditions: Unresectable Angiosarcoma

Treatments: Radiation: BNCT

Study type: Interventional

Funder types: Industry

Identifiers

NCT05601232

CNCT-002/SPM-011-JAM002

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Boron Neutron Capture Therapy (BNCT)

Experimental group

Treatment:

Radiation: BNCT