Recurrent refractory malignant tumor of head and neck &Primary malignant tumor of brain
Conditions
Interventions
Primary malignant tumor of brain:NBB-001+BNCT
Recurrent malignant tumors of the head and neck:NBB-001+BNCT
Sponsors
Xiamen Hongai Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 74 Years
Inclusion criteria
Inclusion criteria: All subjects are required to meet the following requirements: 1. Age =18 years old and 2.5×10^9/L; (2) Neutrophil count >1.0×10^9/L; (3) Platelet count >75×10^9/L; (4) The serum creatinine level of renal function was less than 1.25 times the lower limit of the normal range; (5) Liver function transaminase < 2.5 times the lower limit of normal value. 4. Electrocardiogram showed no clinically significant abnormality. 5.L-18F-BPA PET/CT examination suggested that the boron concentration ratio (TNR) of tumor and normal tissue should be =2.5, and the remaining volume of necrotic parts removed in GTV accounted for =50% of the volume of PET/CT with TNR=2.5. 6. Eligible patients (male and female) who are fertile must consent to the use of a reliable contraceptive method (hormonal or barrier method or abstinence) for at least 12 months after the start of the trial and the last dose; Female patients of childbearing age must have a negative urine pregnancy test within 7 days prior to enrollment. 7. The expected survival time is not less than 4 months. 8. Subjects are required to give informed consent to this study before the experiment and sign a written informed consent voluntarily. Patients with recurrent refractory head and neck malignancies should also meet the following requirements: 1. Histologically confirmed malignant tumors of the head and neck, including nasopharynx, nasal cavity, sinuses, oropharynx, oral cavity, hypopharynx and larynx. 2. Patients with head and neck malignant tumors (squamous cell carcinoma, non squamous cell carcinoma, nasopharyngeal carcinoma) who have undergone surgical treatment, standard radiotherapy, and systemic treatment failure or intolerance, as well as those who are not suitable for systemic treatment or refuse standard treatment. 3.According to RECIST 1.1, there is at least one assessable tumor lesion. 4. For patients who have received radiotherapy, the total cumulative dose of the target lesion does not exceed 75 Gy. Patients with primary malignant brain tumors must simultaneously meet the following requirements: 1. Patients with primary malignant brain tumors confirmed by histology, CNS WHO grade III or IV. 2. For patients who have received radiotherapy, the total cumulative dose of the target lesion does not exceed 65Gy. 3. Patients with measurable lesions according to the RANO (2010) standard.
Exclusion criteria
Exclusion criteria: All patients need to exclude: 1. Lymphoma, any other tumor type expected to respond to cancer with chemotherapy or safe doses of conventional radiation therapy, and patients with active double cancer (contemporaneous double cancer and heterochronous double cancer free for less than 5 years). 2. Patients with distant metastasis. 3. Had undergone major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks before enrollment. 4. The adverse reactions of previous anti-tumor therapy have not recovered to CTCAE V5.0 grade evaluation = Class 1 (except hair loss). 5. History of immunodeficiency, including a positive HIV antibody test (enzyme-linked immunoassay or Western spot assay). 6. Received systemic cancer treatment, including chemotherapy, targeted therapy and immunotherapy, within 4 weeks before enrollment. 7. Patients who have previously received particle implantation therapy. 8. Patients whose target lesions cannot be fully covered by the collimator. 9. Have a pacemaker or non-removable metal implant. 10. 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.); (4) Kidney diseases (chronic renal failure, acute renal failure, nephrotic syndrome, etc.); (5) Heart disease (NYHA functional classification Class III or IV); (6) Patients with active infection; (7) Patients with other high risk. 11. Known alcohol or drug dependence. 12. People with mental disorders or poor compliance. 13. Pregnant or lactating women or patients who have planned to have children within 12 months. 14. Patients with prior severe fructose intolerance. 15. People with phenylketonuria. 16. Patients with cataract symptoms of level 3 (CTCAE V5.0) or higher. 17. The researchers believe that the subjects have any clinical or laboratory test abnormalities or other reasons that make them unsuitable to participate in this clinical study. Patients with relapsed and refractory head and neck malignant tumors should be excluded: 1. There is a risk of arterial hemorrhage associated with tumor involvement, and there is no effective preventive measure. 2. The target lesion received radiation therapy within 3 months prior to enrollment. Patients with primary malignant brain tumors need to exclude: 1. Patients with extracranial metastases. 2. Patients with multiple intracranial lesions on both sides. 3. Active multiple primary cancer patients. 4. Patients with epilepsy or intracranial hypertension that cannot be effectively controlled by medication. 5. Baseline MRI scan shows cerebral hemorrhage grade greater than grade 1, unless relieved to grade 1 and restored before enrollment. 6. Individuals who are unable to undergo MRI examination. 7. The target lesion received full dose (>60 Gy) radiation therapy within 2 months prior to enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR ;LCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS, OS;TTP, DOR, CRR;Stability, failure occurrence, and overall performance evaluation of the instrument; | — |
Countries
China
Contacts
Public ContactPan Jianji, Huang Cheng
Xiamen Hongai Hospital
Outcome results
None listed