A Phase 2 interventional study of BNCT in Unresectable Angiosarcoma, sponsored by Stella Pharma Corporation. Active, not recruiting at 1 site in Japan. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2025-04-09.
Sponsored by Stella Pharma Corporation · Phase 2, Interventional, and Treatment
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.
Exclusion Criteria:
Radiation: BNCT
Patients will be infused SPM-011 intravenously at a dose of 200mg/kg/hr over 2 hours. Thereafter, patient will be infused SPM-011 intravenously at a dose of 100mg/kg/hr and will receive neutron irradiation simultaneously for a certain period of time based on his Boronophenylalanine (BPA) concentration in the blood.
Response rate as assessed by the Independent Review Facility (IRF) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Percentage of patients with response (CR or PR) for target lesions within 90 days after BNCT
Time frame: Baseline until Day90
Response rate as assessed by the investigator according to RECISTv1.1
Percentage of patients with response (CR or PR) for target lesions within 90 days after BNCT
Time frame: Baseline until Day90
Duration of response as assessed by the IRF and the investigator
From the initial occurrence of confirmed CR or PR for target lesions, whichever occurred at first, until confirmed disease progression or death, whichever occurred first
Time frame: Baseline until disease progression or death
Time to response as assessed by the IRF
From the date of BNCT until the initial occurrence of confirmed CR or PR for target lesions, whichever occurred at first
Time frame: Baseline until the initial occurrence of CR or PR
Complete response (CR) rate as assessed by the IRF and the investigator
Percentage of patients with CR for target lesions after BNCT
Time frame: Baseline until the initial occurrence of CR
Disease control rate as assessed by the IRF and the investigator
Percentage of patients with CR, PR and SD for target lesions after BNCT
Time frame: Baseline until the initial occurrence of CR, PR or SD
Overall response rate as assessed by the IRF and the investigator
Percentage of patients with CR or PR after BNCT
Time frame: Baseline until the initial occurrence of CR or PR
Locoregional progression-free survival as assessed by the investigator
From the date of BNCT until confirmed in-field disease progression
Time frame: Baseline until in-field disease progression
Extra-regional relapse-free survival as assessed by the investigator
From the date of BNCT until confirmed extra-field disease progression (new lesions)
Time frame: Baseline until extra-field disease progression
Progression-free survival as assessed by the IRF and the investigator
From the date of BNCT until confirmed disease progression or death, whichever occurred first
Time frame: Baseline until disease progression or death
Maximum percent change in sum of tumor diameters of target lesions as assessed by the IRF and the investigator
Maximum percent change in sum of tumor diameters of target lesions within 90 days after BNCT
Time frame: Baseline until Day90
Overall survival
From the date of BNCT until death from any causes
Time frame: Baseline until death
Plan to share: No
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This study is active, not recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Stella Pharma Corporation