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.
99 studies on the registry are indexed under Hemangiosarcoma; 16 are open to participants now.
This study's planned enrollment of 10 is below the median of 64 across 83 interventional studies indexed under Hemangiosarcoma.
Browse Hemangiosarcoma studies →Stella Pharma Corporation is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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