Unresectable locally recurrent head and neck squamous cell carcinoma or unresectable locally advanced head and neck non squamous cell carcinoma
Conditions
Interventions
Experimental group:Borofalan [10B] for Injection and BNCT
Sponsors
Dongguan People's 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 trial and voluntarily sign a written informed consent form; 2. Age>=18 years old and =80 ×10^9/L, absolute neutrophil count (ANC) >=1.5×10^9/L, absolute white blood cell count (WBC) >=2.5×10^9/L, hemoglobin >= 80 g/L (no adjuvant treatment such as EPO, G-CSF or GM-CSF within 14 days before screening, and no blood transfusion including red blood cell and platelet transfusion within at least 7 days before dosing); (2) Renal function: serum creatinine =3 months; 11. Patients who have received radiotherapy, the total cumulative dose of the target lesion does not exceed 75 Gy; 12. Eligible patients of childbearing potential (male and female) must agree to use a reliable method of contraception (hormonal or barrier method or abstinence) for at least 12 months after the start of the trial through medication; Female patients of childbearing potential must have a negative blood pregnancy test within 7 days prior to enrollment.
Exclusion criteria
Exclusion criteria: 1. Patients with lymphoma, any other tumor type that is expected to respond to cancer with chemotherapy or conventional radiotherapy at a safe dose, head and neck squamous cell carcinoma combined with lung cancer and multiple primary cancers within five years; 2. Patients with distant metastases; 3. Tumor involvement of carotid artery with risk of arterial hemorrhage, and there is no effective means of prevention; 4. Positive hepatitis B surface antigen and HBV-DNA > 1000IU/mL at screening; 5. Received radiotherapy within 3 months of the target lesion before enrollment; 6. Subjects who have participated in clinical trials before enrollment and are less than one month away from the last medication; 7. Patients who have received previous particle implantation therapy; 8. Surgical operation of major organs (excluding needle biopsy) or significant trauma within 4 weeks before enrollment; 9. Patients with grade =3 (CTCAE V5.0) symptoms at the target site when signing the informed consent form; 10. Those who have been found to have moderate or severe caries at the time of signing the informed consent form and have not completed treatment, and there is a risk of infection spread (such as pulpitis, apical periodontitis, obvious periodontal abscess, etc.), and it is judged by the investigator to affect the safety or efficacy of BNCT treatment, or those who have obvious oral infections that have not completed treatment before screening, and those who have not healed the tooth extraction wound, or those who are expected to need oral invasive procedures during BNCT treatment; 11. Patients with the following risk factors for cerebrovascular disease: (1) Patients with severe stenosis (stenosis =50%) in the carotid artery or vertebrobasilar artery system confirmed by imaging or clinical diagnosis, or unstable atherosclerotic plaque has been formed, and it is considered by the investigator that radiation therapy may induce ischemic stroke; (2) Those who have a history of severe ischemic cerebrovascular disease such as severe cerebral infarction and transient ischemic attack (TIA) in the past, and the risk of recurrence is considered to be high by the investigator. 12. Patients with severe allergies (rashes, allergic reactions, serum sickness) to drugs or contrast agents in the past, and patients who are allergic to BPA and its excipients; 13. History of immunodeficiency, including positive HIV antibody test (enzyme-linked immunoassay or Western spot method, chemiluminescence method); 14. Received systemic cancer therapy within 4 weeks or 5 half-lives of the drug (whichever is shorter) before enrollment, including chemotherapy and targeted therapy and immunotherapy; 15. Patients with myocardial infarction, unstable angina pectoris, or poorly controlled arrhythmias within 6 months prior to planned BNCT; 16. Patients who are unable to lie flat in the treatment room for at least 60 minutes; 17. Have a pacemaker or non-removable metal implant; 18. 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 disease (chronic renal failure, acute renal failure, nephrotic syndrome, etc.); (5) Cardiac disease (NYHA Functional Classification III. or IV); (6) Other serious complications; 19. Subjects with patients with active infection requiring system
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety( Adverse event, Serious Adverse Event, Radiation oncology collaborative group (RTOG) grading criteria for acute / late radiation injury, etc); | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Overall Response (DOR);Objective Response Rate (ORR);Local Control Rate (LCR);Disease Control Rate (DCR);Complete Response Rate (CRR);Progression-Free Survival (PFS);Overall survival (OS);Pharmacokinetics (PK);Device performance evaluation;Correlation between LAT1 expression and therapeutic effect; | — |
Countries
China
Contacts
Public ContactZhigang Liu
Dongguan People's Hospital
Outcome results
None listed