Squamous cell carcinoma of head and neck
Conditions
Interventions
Sponsors
Xiyuan Hospital of CACMS
Eligibility
Sex/Gender
All
Age
70 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age = 70 years old and = 80 years old; 2. Subjects must sign a written informed consent prior to study enrollment and must be willing and able to comply with the visit, treatment plan, laboratory testing, and other requirements of the study plan; 3. Stage IV head and neck squamous cell carcinoma confirmed by histology; 4. Elderly or frail patients with recurrent or metastatic head and neck squamous cell carcinoma without systematic treatment after radical surgery or radiotherapy; Patients with head and neck squamous cell cancer who are not eligible for surgery or radiotherapy; 5.ECOG 0-2 points; 6. Measurable tumor lesions according to RECIST v1.1; 7. Biochemical (obtained within 14 days prior to study enrollment and measured within the specified range below) ; (1) White blood cells =2000/µL (2.0×109/L); (2) Neutrophils =1500/µL (1.5×109/L); (3) Platelets =100 x103/µL (100×109/L); (4) Hemoglobin =9.0 g/dL (90 g/L) or =5.6 mmol/L; (5) Serum creatinine 1.5×ULN or creatinine clearance (CrCl) > 40 mL/min(using Cockcroft-Gault formula): Female CrCl=(140- age)× Body weight (kg)× 0.85 / (72×Scr mg/dl) Male CrCl=(140- age)× Body weight (kg)× 1.00 / (72×Scr mg/dl) (6) AST/ALT=3 x ULN; (7) Total bilirubin =1.5×ULN (except Gilbert syndrome).
Exclusion criteria
Exclusion criteria: 1. Patients with active brain or meningeal metastasis; 2. Patients with squamous cell carcinoma of unknown origin; 3. Patients with uncontrolled malignant tumors within the past 3 years; 4. Patients with a history of primary immunodeficiency or allogeneic organ transplantation; 5. Have untreated and/or uncontrolled cardiovascular disease, and/or symptomatic heart dysfunction (unstable angina pectoris, congestive heart failure, myocardial infarction within the past year or ventricular arrhythmia requiring medical treatment, history of second or third degree atrioventricular block). Patients with a history of major heart disease, even if controlled, must have >50% LVEF within 12 weeks prior to immunotherapy; 6. Patients with severe liver injury (total bilirubin > 3 ULN and any AST); 7. Physical and laboratory test results: a) Positive hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody), indicating acute or chronic infection. b) Known history of positive testing for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS). c) Any Level 4 laboratory anomaly; 8. Allergy and adverse drug reactions: history of allergy to drug ingredients; A history of severe allergic reactions to any monoclonal antibody; 9. Active serious clinical infections, including active tuberculosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective remission rate (ORR);Disease control rate (DCR);Overall survival (OS); | — |
Countries
China
Contacts
Public ContactZhang Tong
Xiyuan Hospital of CACMS
Outcome results
None listed