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

JRCT ID: jRCT2031240246

Registered date:31/07/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Thoracic solid malignant tumor
• Date of first enrollment: 31/07/2024
• Target sample size: 30
• Study type: Interventional

Intervention(s)

- Intravenous administration of investigational drug.
1st time/2nd time
- Neutron irradiation of the clinical target volume with the investigational device.
1st time /2nd time
- Intravenous injection of 18F-FBPA and radiation exposure from PET-CT scan.

Outcome(s)

Primary Outcome

- Occurrence rate of dose-limiting toxicity
- Response rate (RECIST v1.1)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

- 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.
- Patients whose longest diameter sum of the lesions to be treated is 15 cm or less.

Exclude criteria

- 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.

Related Information

• Primary Sponsor: Hayashi Toshimitsu