NCT06603987Enrolling by invitationPhase 1/2
Using CICS-1 and SPM-011 and ［18F］FBPA Commissioned by CICS and Sumitomo Heavy Industries and STELLA PHARMA
Phase I/II Basket Trial: Boron Neutron Capture Therapy (BNCT) Using CICS-1 and SPM-011 for Patients With Recurrent Solid Malignant Thoracic Tumors That Are Unresectable and Perceived Challenging to Treat With Standard Treatment
Source: ClinicalTrials.gov · Last updated 19 Nov 2025
Brief summary (registry, in English)
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 and are unresectable. With "lung," "heart," "liver," "spinal cord," and "esophagus" as common risk organs in the treatment plan for BNCT using therapeutic CT to evaluate the safety and efficacy of BNCT in patients with unresectable and recurrent thoracic solid tumors which are difficult to treat with standard radiation and drug therapy. To evaluate the safety of ［18F］FBPA synthesized with MPS200FBPA. In addition, the usefulness of ［18F］FBPA-PET testing to determine the appropriateness of performing BNCT will be evaluated in an exploratory manner.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 12 Sept 2024
- Start date
- 10 Apr 2025
- Primary completion date
- 31 Oct 2028
- Lead sponsor
- Stella Pharma Corporation
- NCT number
- NCT06603987
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 30
- From 10 Apr 2025 to the primary completion date, 31 Oct 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Patients with active disease or active double cancers other than target lesions.
Other
- Patients with imaging findings that affect imaging evaluation of the tumor, such as ground-glass opacities
Who the study is looking for
- 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.
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| ORIX Kouraibashi Bldg. 8F 3-2-7 Kouraibashi Chuo-ku Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.