Relapsed and refractory head and neck malignancies or primary brain malignancies
Conditions
Interventions
First dose group:The maximum dose for the first dose group was 500 mg/kg (over 10% allowed), and neutron irradiation using the accelerator boron neutron capture therapy system was performed during the
Second dose group:Subjects in the second dose group will receive a maximum dose of 750 mg/kg (more than 10% is allowed) and will be irradiated with neutrons using the accelerator boron neutron capture
Sponsors
Xiamen Honghai Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: All patients must meet the following requirements A. Age >= 18 years and 2.5 × 10^9/L; (2) neutrophil count > 1.0 × 10^9/L; (3) platelet count > 75 × 10^9/L; (4) renal function serum creatinine level less than 1.25 times the lower limit of the normal range; (5) liver function transaminases = 2.5. F. Eligible patients of childbearing potential (men and women) 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 a negative urine pregnancy test within 7 days before inclusion. G. The expected survival time is not less than 3 months. H. Subjects must give informed consent to this study prior to the trial and voluntarily sign a written informed consent form. Patients with relapsed or refractory head and neck malignancies are required to meet the following requirements A. Histologically confirmed head and neck malignancies, disease range: head and neck organs such as nasopharynx, nasal cavity, paranasal sinuses, oropharynx, oral cavity, hypopharynx, and larynx. B. Patients with stage III and IV disease who have failed standard treatment according to the Chinese Society of Clinical Oncology (CSCO) guidelines for diagnosis and treatment of cancer, are unwilling to receive standard treatment, and cannot be treated in other ways. C. At least one evaluable tumor lesion according to RECIST 1.1. D. In patients who have received radiotherapy, the total cumulative dose to the target lesion does not exceed 75 Gy. Patients with primary brain malignancies must meet the following requirements A. Patients with histologically confirmed primary brain malignancy, CNS WHO grade III or IV. B. In patients who have received radiotherapy, the total cumulative dose to the target lesion does not exceed 65 Gy. C. Patients with measurable disease according to RANO (2010) criteria.
Exclusion criteria
Exclusion criteria: All patients need to be excluded A. Major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to enrollment. B. Adverse reactions from prior anticancer therapy that have not recovered to CTCAE V5.0 grade 1 on baseline MRI scan unless resolved to grade 1 and recovered prior to enrollment. E. Inability to undergo MRI. F. Received full-dose (> 60 Gy) radiation therapy within 2 months of target lesion prior to enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment related toxicity;acute radiation injury;Long term radiation damage;CTC AE; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Progress Free Survival;Duration of Response;Overall Survival;Stability of apparatus; | — |
Countries
china
Contacts
Public ContactJianji Pan
Xiamen Honghai Hospital
Outcome results
None listed