Recurrent malignant tumors of the head and neck
Conditions
Interventions
Phase Ia: dose escalation phase:Three dose groups were planned for phase Ia: 412.5mg/kg in the first dose group, 550mg/kg in the second dose group, and 687.5mg/kg in the third dose group. 3-6 patients
Phase II 75mg/kg/h lasting 1.5 hours b.550mg/kg dose group: Phase I 200mg/kg/h lasting 2 hours, phase II 100mg/kg/h lasting 1.5 hours
Phase I 250mg/kg/h c.687.5mg/kg dose group: lasting 1.5 hours for
Phase Ib: dose expansion phase:It is planned to select an RP2D dose and enrol 18-30 subjects.
Participants enrolled in the Phase Ib
Sponsors
Ethics Committee of Xiamen Hongai Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects must give informed consent to this study before the experiment and sign a written informed consent voluntarily; 2. Age =18 years old and <75 years old, gender is not limited; 3.ECOG physical strength score 0-2 points; 4. Histologically confirmed malignant tumors of the head and neck, including nasopharynx, nasal cavity, sinuses, oropharynx, oral cavity, hypopharynx, larynx and other head and neck organs, as well as blood vessels, nerves, lymph nodes, bone and soft tissues of the head and neck; 5. Patients with head and neck malignancies (squamous cell carcinoma, non-squamous cell carcinoma, nasopharyngeal carcinoma) with local recurrence or regional lymph node recurrence after surgical treatment, standard radiotherapy and systemic treatment failure or intolerance, and patients not suitable for systemic treatment of head and neck malignancies; The specific provisions are as follows: (1) Head and neck squamous cell carcinoma: patients who have received multi-disciplinary treatment failure or intolerance including standard treatment such as radiotherapy, platinum-containing chemotherapy and immunotherapy. (2) Nasopharyngeal carcinoma: Patients who have received multidisciplinary treatment failure or intolerance including standard treatment such as radiotherapy, platinum-containing chemotherapy and immunotherapy. (3) Head and neck non-squamous cell carcinoma: patients who have received failure or intolerance of multidisciplinary treatment including radiotherapy and systemic therapy. 6. Multiple target lesions need to be covered in the same irradiation field; 7. There is at least one evaluable tumor lesion according to RECISTv1.1 criteria; 8.18F-BPA-PET/CT examination suggested that the boron concentration ratio (TNR) of tumor to normal tissue should be =2.5; 9. No clinically significant abnormality in electrocardiogram; 10. Adequate blood system function, liver function and kidney function: (1) Platelets (PLT) =80 ×109/L, neutrophil absolute value count (ANC) =1.5×109/L, white blood cell absolute value count (WBC) =2.5×109/L, hemoglobin =8g/dL (no EPO, G-CSF or GM-CSF adjuvant treatment within 14 days, And have not received blood transfusions including red blood cells and platelets within at least 7 days prior to administration); (2) Renal function: serum creatinine =1.25×ULN; (3) Liver function: AST and ALT=3×ULN; 11. Expected survival =3 months; 12. In patients who have received radiotherapy, the total cumulative dose of the target lesion does not exceed 75 Gy; 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; Women of reproductive age must have a negative pregnancy test within 7 days prior to enrollment.
Exclusion criteria
Exclusion criteria: 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. The tumor is associated with the risk of massive arterial bleeding, and there is no effective preventive means. 4. The target lesion received radiotherapy within 3 months before enrollment. 5. Patients who have previously received particle implantation therapy. 6. Had undergone major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks before enrollment. 7. The adverse reactions of previous anti-tumor therapy have not recovered to CTCAE V5.0 grade evaluation = Class 1 (except hair loss). 8. History of immunodeficiency, including a positive HIV antibody test (chemiluminescence, enzyme-linked immunoassay, or Western spot assay). 9. Received systemic cancer treatment, including chemotherapy, targeted therapy and immunotherapy, within 4 weeks before enrollment. 10. Patients who are unable to lie flat or remain seated in the treatment room for at least 60 minutes. 11. Have a pacemaker or non-removable metal implant. 12. Patients with serious complications including but not limited to the following: (1) uncontrolled diabetes; (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 grade III or ?). (6) Patients with active infection. (7) Patients with other high risk. 13. Known alcohol or drug dependence. 14. People with mental disorders or poor compliance. 15. Pregnant or lactating women or patients who have planned to have children within 12 months. 16. Patients with prior severe fructose intolerance. 17. People with phenylketonuria. 18. Cataract symptoms are grade 3 (CTCAE V5.0) or higher. 19. People who are allergic to boron drugs. The investigator believes that the subjects are not eligible to participate in this clinical study due to any clinical or laboratory abnormalities or for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| LCR;ORR;DOR; | — |
Countries
China
Contacts
Public ContactPan Jianji, Huang Cheng
Xiamen Hongai Hospital
Outcome results
None listed