head and neck squamous cell carcinoma
Conditions
Interventions
Treatment group:Brachytherapy +Camrelizumab
Sponsors
Sichuan Cancer Hopspital/Institute
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Recurrent squamous cell carcinoma of head and neck confirmed by pathology, CPS = 1; 2. The clinical stage is T1-4 (TNM stage of the eighth edition); 3. Regional lymph node recurrence = 2; 4. ECOG 0-2 points; 5. Gender unlimited, 18 = age = 80 years old; 6. No distant metastasis; 7. The patient refuses or cannot tolerate the operation; 8. No contraindication to radiotherapy; 9. Have received radiotherapy of at least 50GY 6 months ago; 10. Tumor anatomy and localization suitable for brachytherapy technology; 11. The main organs function normally, that is, they meet the following standards: a) Blood routine examination (no blood transfusion within 14 days, no use of hematopoietic stimulator drugs for correction): hemoglobin (Hb) = 90g/L; Absolute neutrophil count (ANC) = 1.5 × 109/L Platelet (PLT) = 100 × 109/L White blood cell count (WBC) = 3.0 × 109/L b) Biochemical examination: ALT and AST = 2.5 × Upper limit of normal value (ULN) (= 5 for patients with liver metastasis × ULN) Total serum bilirubin (TBIL) = 1.5 × ULN Serum creatinine (Cr) = 1.5 × ULN or creatinine clearance = 50ml/min; c) Coagulation function: activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) = 1.5 × ULN d) Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) = 50%; 12. Women of childbearing age must have a negative pregnancy test (serum or urine) within 14 days before enrollment, and voluntarily use appropriate methods of contraception during the observation period and within 3 months after the last administration of the study drug; For men, they should be surgically sterilized or agree to use appropriate methods of contraception during the observation period and within 3 months after the last administration of the study drug; 13. The subjects voluntarily participated in the study, signed the informed consent form, had good compliance and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Relapse with distant metastasis; 2. Pregnant or lactating women; 3. Have connective tissue disease; 4. Congenital diseases with increased radiosensitivity, such as ataxia telangiectasia; 5. Known symptomatic or untreated brain metastasis or other central nervous system (CNS) metastasis; 6. There are meningeal metastasis, brain stem metastasis and liver metastasis; 7. Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage; 8. Have uncontrollable clinical cardiac symptoms or diseases, such as (1) heart failure of NYHA II and above; (2) Unstable angina pectoris; (3) Myocardial infarction occurred within 1 year; (4) Patients with clinically significant supraventricular or ventricular arrhythmia who need clinical intervention; 9. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), Untreated active hepatitis (hepatitis B, defined as positive detection result of hepatitis B B virus surface antigen [HBsAg], HBV-DNA = 500 IU/ml and abnormal liver function; hepatitis C, defined as positive detection of hepatitis C antibody [HCV Ab], HCV-RNA higher than the detection limit of the analytical method and abnormal liver function) or co infection of hepatitis B and hepatitis C; 10. Subjects with active pulmonary tuberculosis; 11. Persons who have received solid organ transplantation; 12. Patients with severe irAE during first-line chemotherapy combined with immunotherapy (such as = grade 3 pneumonia, enteritis, rash, hepatitis, Kidney damage, pancreatitis, hypophysitis, bone marrow depression, = Grade 2 cardiotoxicity, encephalitis, etc.). Patients with hypothyroidism supplemented with thyroxine tablets and patients with elevated blood glucose treated with hypoglycemic therapy can be considered for inclusion; 13. Have any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism after hormone replacement therapy); Patients with childhood asthma who have completely relieved and do not need any intervention or vitiligo after adulthood can be included, and patients who need medical intervention with bronchodilators cannot be included; 14. Complicated with severe infection (such as intravenous drip of antibiotics, antifungal or antiviral drugs) within 2 weeks before the first administration, or fever of unknown cause>38.5 ° C during screening/before the first administration; 15. Subjects who need to receive glucocorticoid (prednisone>10 mg/day or other similar drugs with equivalent dose) or other immunosuppressants due to certain conditions within 14 days before the administration of the study drug; 16. He received systemic anti-tumor treatment 4 weeks before the start of the study, including chemotherapy, immunotherapy, and biological therapy (PD-1/PD-L1 monoclonal antibody, tumor vaccine, cytokines, or growth factors that control cancer); 17. Other circumstances deemed unsuitable by the researcher; 18. Failure to sign informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| two year overall survival rate;Safety and tolerance;Quality of life;Response rate after treatment; | — |
Countries
China
Contacts
Public ContactLu Shun
Sichuan Cancer Hopspital/Institute
Outcome results
None listed