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

Phase 2

Active, not recruiting

• Conditions: Unresectable Angiosarcoma
• Interventions: Radiation: BNCT

• Registration Number: NCT05601232
• Lead Sponsor: Stella Pharma Corporation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-27
• Study First Submitted QC: 2022-10-27
• Study Start: 2022-11-01
• Study First Posted: 2022-11-01
• Primary Completion: 2024-11-30
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-06
• Last Update Posted: 2025-04-09
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Boron Neutron Capture Therapy (BNCT)	BNCT	-

Primary Outcome Measures

Name	Time	Method
Response rate as assessed by the Independent Review Facility (IRF) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1	Baseline until Day90	Percentage of patients with response (CR or PR) for target lesions within 90 days after BNCT

Secondary Outcome Measures

Name	Time	Method
Response rate as assessed by the investigator according to RECISTv1.1	Baseline until Day90	Percentage of patients with response (CR or PR) for target lesions within 90 days after BNCT
Duration of response as assessed by the IRF and the investigator	Baseline until disease progression or death	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
Locoregional progression-free survival as assessed by the investigator	Baseline until in-field disease progression	From the date of BNCT until confirmed in-field disease progression
Time to response as assessed by the IRF	Baseline until the initial occurrence of CR or PR	From the date of BNCT until the initial occurrence of confirmed CR or PR for target lesions, whichever occurred at first
Complete response (CR) rate as assessed by the IRF and the investigator	Baseline until the initial occurrence of CR	Percentage of patients with CR for target lesions after BNCT
Disease control rate as assessed by the IRF and the investigator	Baseline until the initial occurrence of CR, PR or SD	Percentage of patients with CR, PR and SD for target lesions after BNCT
Extra-regional relapse-free survival as assessed by the investigator	Baseline until extra-field disease progression	From the date of BNCT until confirmed extra-field disease progression (new lesions)
Progression-free survival as assessed by the IRF and the investigator	Baseline until disease progression or death	From the date of BNCT until confirmed disease progression or death, whichever occurred first
Maximum percent change in sum of tumor diameters of target lesions as assessed by the IRF and the investigator	Baseline until Day90	Maximum percent change in sum of tumor diameters of target lesions within 90 days after BNCT
Overall survival	Baseline until death	From the date of BNCT until death from any causes
Overall response rate as assessed by the IRF and the investigator	Baseline until the initial occurrence of CR or PR	Percentage of patients with CR or PR after BNCT

Trial Locations

Locations (1)

National Cancer Center Hospital; 🇯🇵 Tokyo, Japan