Advanced solid tumor
Conditions
Interventions
Recurrent advanced solid tumors:NBB-001+BNCT
Sponsors
Xiamen Humanity Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 74 Years
Inclusion criteria
Inclusion criteria: All subjects were required to fulfill the following requirements: 1. age = 18 and 2.5 x 109/L; (2) Neutrophil count > 1.0 x 109/L; (3) Platelet count >75×109/L; (4) Lymphocyte count >0.6×109/L; (5) Renal function serum creatinine level less than 1.25 times the lower limit of normal range; (6) Liver function aminotransferase <2.5 times the lower limit of the normal range. 11. Electrocardiogram without clinically significant abnormalities. 12. eligible patients (male and female) of childbearing potential must agree to use a reliable method of contraception (hormonal or barrier method or abstinence) at the start of the trial and for at least 12 months after the last dose; female patients of childbearing potential must have had a negative pregnancy test (blood or urine sample) within 7 days prior to enrollment. 13. Subjects must give informed consent for this study prior to the trial and voluntarily sign a written informed consent form.
Exclusion criteria
Exclusion criteria: All patients need to be excluded: 1. lymphomas, intra-abdominal tumors, any other tumor type for which chemotherapy or safe doses of conventional radiation therapy are expected to be effective for the cancer, and patients with active double cancers (synchronous double cancers and heterochronic double cancers within 5 years of disease-free). 2. patients with distant metastases that cannot be fully covered by an irradiation field directed at a locally recurrent lesion. 3. patients whose target lesions can be treated with existing standardized treatments, such as chemotherapy, surgery and radiotherapy. 4. major organ surgery (excluding puncture biopsy) or significant trauma within 4 weeks prior to enrollment. 5. Adverse effects of prior antitumor therapy that have not recovered to CTCAE V5.0 grade = 1 (except for some toxic side effects that are difficult to recover, such as alopecia, etc.). 6. history of immunodeficiency, including positive HIV antibody test (enzyme immunoassay or Western blotting). 7. systemic cancer treatment, including chemotherapy and targeted therapy and immunotherapy, within 4 weeks prior to enrollment. 8. Patients who have received particle implantation therapy in the treatment area within the previous 2 years. 9. allergy to boron drugs and their excipients. 10. have pacemakers or non-removable metallic implants. 11. patients with serious complications including, but not limited to, the following: (1) Uncontrolled diabetes mellitus; (2) Uncontrolled hypertension; (3) Chronic lung disease (obstructive pneumonia, interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.), acute lung disease with short-term difficulty in recovering from treatment or susceptibility to relapse after treatment; (4) Kidney disease (chronic renal failure, acute renal failure, nephrotic syndrome, etc.); (5) Heart disease (NYHA Functional Classification III or IV); Note: If the neutron irradiation field affects the heart, patients with ischemic heart disease such as myocardial infarction, unstable angina pectoris, and other patients with moderate-to-severe cardiovascular disease should be excluded. (6) Patients with active infections; (7) Patients with brain diseases that seriously affect the evaluation of this study; (8) Diseases that severely affect swallowing function (Note: except for target lesions of pharyngeal tumors that require treatment under the study). (9) Patients with other high risk conditions. 12. 12. Known alcohol or drug dependence. 13. 13. persons with mental disorders or poor compliance. 14. pregnant or lactating women. 14. pregnant or breastfeeding women or patients planning to have a child within 12 months. 15. patients with previous severe intolerance to fructose. 16. patients with phenylketonuria. 17. patients with grade 3 (CTCAE V5.0) or higher cataract symptoms for tumors that may affect the eye in the neutron irradiation field, such as head and neck tumors, brain tumors. 18. subjects who, in the opinion of the investigator, have any clinical or laboratory test abnormality or other reasons that make them unsuitable for participation in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate;Local control rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival;Stability, failure occurrence, and overall performance evaluation of the instrument; | — |
Countries
China
Contacts
Public ContactPan Jianji, Huang Cheng
Xiamen Humanity Hospital
Outcome results
None listed