head and neck squamous cell carcinoma
Conditions
Interventions
Experimental group:Iodine-125 seed implantation with Pembrolizumab
Sponsors
Hebei General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Age range from 18 to 80 years old, regardless of gender; 2. Confirmed head and neck squamous cell carcinoma by cytology and/or histology; 3. Guidelines for staging recurrent and metastatic head and neck squamous cell carcinoma that cannot be operated on; 4. Single lesion diameter = 6cm; 5. Kps score = 60; 6.Expected survival time = 3 months; 7.No other serious comorbidities; 8.The main organ function meets the following standards within 7 days before treatment: Blood routine examination standard (without blood transfusion within 14 days): hemoglobin (HB) = 100g/L, absolute neutrophil count (ANC) = 1.5 × 10 ^ 9/L, platelet count (PLT) = 80 × 10 ^ 9/L; Total bilirubin (TBIL) = 1.5 times the upper limit of normal value (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase AST = 2.5 ULN, if accompanied by liver metastasis, ALT and AST = 5 ULN, serum creatinine (Cr) = 1.5 ULN, and creatinine clearance rate (CCr) = 60ml/min; Cardiac ultrasound: Left ventricular ejection fraction (LVEF) = lower limit of normal value (50%); PT does not exceed the upper limit of the control normal value for 3 seconds or INR<2.3; 9.The patient voluntarily participated in this study and signed an informed consent form.
Exclusion criteria
Exclusion criteria: 1.Histology does not conform to squamous cell carcinoma of the head and neck, and has previously or currently suffered from malignant tumors of other organs or organs; 2. Local treatment (such as radiotherapy, particle implantation, ablation treatment or irreversible electroporation treatment) was performed for the tumor before enrollment: 3. Pregnant or lactating women; 4. Diagnosed as an immune deficiency patient; 5. Severe heart disease, such as congestive heart failure>New York Heart Association (NYHA) Class II, active coronary artery disease, severe arrhythmia requiring treatment, etc.: 6.Uncontrollable hypertension (even after using three antihypertensive drugs, the diastolic blood pressure cannot be controlled below 90mmHg); 7.Active clinical severe infection (>Level 2 NCI-CTCAE4.0 version) 8.Presence of active pulmonary tuberculosis; 9.Chronic renal insufficiency; 10.Other organ failure: 11. Organ transplant recipients: 12.Have a history of serious mental illness: 13.Other investigators believe or may endanger the safety of patient safety and the patients' compliance with the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease control rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival;Overall survival;Quality of Life ; | — |
Countries
China
Contacts
Public ContactGuo Litao
Hebei General Hospital
Outcome results
None listed