Patients with locally recurrent head and neck squamous cell carcinoma
Conditions
Interventions
12 Gy-Eq Group:Boron [10B] Bortezomib for injection 500 mg/kg, intravenous infusion
neutron irradiation dose 12 Gy-Eq
15 Gy-Eq Group:Boron [10B] Bortezomib for injection 500 mg/kg, intravenous infusion
neutron irradiation dose 15 Gy-Eq
18 Gy-Eq Group:Boron [10B] Bortezomib for injection 500 mg/kg, intravenous infusion
neutron irradiation dose 18 Gy-Eq
Phase Ib trial group:Boron [10B] Farron for injection and cadmium neutron capture therapy system for the treatment of patients with locally recurrent head and neck cancer or locally advanced head and
Sponsors
Huzhou Center Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 years = 3 × 10^9/L, neutrophil count (ANC) >= 1.5 × 10^9/L, hemoglobin >= 90g/L, platelet count (PLT) >= 75 × 10^9/L; (2) Renal function: glomerular filtration rate (eGFR) or creatinine clearance rate (CrCl) > 60mL/min, urinary protein = 30g/L; (4) Coagulation function: If there is a prolongation of clotting time, it should meet both the international normalized ratio (INR) < 1.5 and the activated partial thromboplastin time (APTT) prolongation < 1.5 × ULN; 8. Patients of childbearing potential (male and female) must agree to use effective contraceptive methods for at least 12 months after the start of the trial and BNCT treatment; female patients of childbearing potential must have a negative pregnancy test before medication; 9. Voluntary signing of informed consent form.
Exclusion criteria
Exclusion criteria: 1. Individuals with a history of other known malignant tumors within the past 5 years, excluding locally cured tumors such as cervical carcinoma in situ, basal cell carcinoma of the skin, and prostate carcinoma in situ 2. According to the researcher's evaluation, patients who have no mucosa within 1-5cm of the skin surface on the planned irradiation path 3. Tumor tissue involving large blood vessels in the neck and exposed to the skin surface, or tumor tissue invading neck blood vessels with a risk of major bleeding but lacking effective preventive measures 4. If the target lesion has received >= 2 courses of radiotherapy, or if the interval between the last radiotherapy/particle implantation of the target lesion and BNCT treatment is less than 3 months, and the researcher evaluates that BNCT treatment is not suitable 5. Patients who have received BNCT treatment in the past 6. Those with an expected survival period of = 160mmHg and/or diastolic blood pressure >= 100mmHg) 17. Those who suffer from serious complications and have been assessed by researchers as unsuitable for BNCT treatment, including but not limited to the following situations: (1) Poor control of diabetes (after standardized treatment, the fasting blood glucose level is still higher than 11.1 mmol/L); (2) Kidney diseases (chronic renal failure, acute renal failure, nephrotic syndrome, etc.); (3) Severe mental illness patients and those with poor epilepsy control 18. Uncontrolled active infections that have been assessed by researchers as unsuitable for BNCT treatment, including but not limited to: (1) At the time of enrollment, hepatitis B surface antigen was positive and HBV-DNA > 1000 IU/ml (e
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life (QoL);Single Treatment Time, Preparation Time, Equipment Reliability Assessment, System Usability, Stability Pass Rate, and Overall Pass Rate;Pharmacokinetic Parameters of Boron-10-Boronophenylalanine in Blood and Urine;Pharmacokinetic Parameters of Boron-10 in Blood;Local Control Rate (LCR), Disease Control Rate (DCR), Duration of Response (DOR), Progression-Free Survival (PFS), Overall Survival (OS);Safety Endpoints (including Adverse Events, Vital Signs, Physical Examination, Laboratory Tests, Electrocardiography);Optimal Irradiation Dose;Device Performance; | — |
Countries
China
Contacts
Public ContactYan Qiang
Huzhou Center Hospital
Outcome results
None listed