Thoracic solid malignant tumor
Conditions
Interventions
- 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
Sponsors
Hayashi Toshimitsu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Occurrence rate of dose-limiting toxicity - Response rate (RECIST v1.1) | — |
Contacts
Public Contactinformation Clinical trials
Stella Pharma Corporation
Outcome results
None listed