Status:
ENROLLING_BY_INVITATION
Using CICS-1 and SPM-011 and ［18F］FBPA Commissioned by CICS and Sumitomo Heavy Industries and STELLA PHARMA
Lead Sponsor:
Stella Pharma Corporation
Collaborating Sponsors:
Cancer Intelligence Care Systems, Inc.
Sumitomo Heavy Industries, Ltd.
Conditions:
Thoracic Solid Malignant Tumor
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
PHASE2
Brief Summary
To evaluate the safety and efficacy of Boron Neutron Capture Therapy (BNCT) in patients with recurrent thoracic solid tumors that are difficult to treat with standard radiation therapy or drug therapy...
Eligibility Criteria
Inclusion
- Written informed consent must be obtained from the subject.
- Patients with histopathological diagnosed malignant tumor (except cutaneous angiosarcoma)
- Measurable disease, as defined by RECIST v1.1.
- Patients diagnosed with recurrent malignant tumors that are unresectable and perceived challenging to treat with standard treatment.
- Patients with ECOG performance status score of 0 or 1.
Exclusion
- Patients with active disease or active double cancers other than target lesions.
- Patients with imaging findings that affect imaging evaluation of the tumor, such as ground-glass opacities
- Patients who received radiation therapy exceeding 65 Gy as a prior treatment for the target lesion.
- Any serious concomitant disease that precludes completion of the study treatment.
- Patients with remaining complications of Grade 3 or higher related to prior radiation therapy in the irradiation field.
Key Trial Info
Start Date :
April 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06603987
Start Date
April 10 2025
End Date
October 31 2028
Last Update
November 19 2025
Active Locations (1)
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1
ORIX Kouraibashi Bldg. 8F 3-2-7 Kouraibashi Chuo-ku
Osaka, Osaka, Japan, 541-0043