terminal head and neck squamous cell carcinoma
Conditions
Interventions
Control group:No targeted therapy
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 years and more; 2. Histologically or cytologically confirmed diagnosis of SCCHN; 3. Recurrent and/or metastatic SCCHN, not suitable for local-regional treatment. Patients with recurrent disease only (no metastases) must have received prior radiotherapy (as adjuvant treatment after surgery or as treatment for locally advanced SCCHN) as part of loco-regional treatment, and the radiotherapy and the radiotherapy must have beencompleted more than 6 months before screening imaging; 4. Presence of at least 1 measurable lesion according to RECIST version 1.1; 5. Signed written informed consent before any trial-related activities are carried out; 6. ECOG performance status of 0 or 1; 7. Neutrophils 1.5*10^9/L, platelet count 100*10^9/L, and hemoglobin 90 g/L; 8. Total bilirubin 2*upper limit of normality (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 3*ULN (if liver metastasis exists, ALT and AST 5*ULN); 9. Serum corrected calcium, potassium and magnesium corrected within normal range (electrolyte correction is permitted during screening); 10. Creatinine clearance ?60 mL/minute (24 hours creatinine clearance might be requested by the investigator for confirmation, if calculated creatinine clearance is <60 mL/min); 11. Effective contraception if procreative potential exists (applicable for both male and female subjects) until at least 3 months after the last dose of trial treatment.
Exclusion criteria
Exclusion criteria: 1. Prior systemic chemotherapy, except if given as part of multimodal treatment for locally advanced SCCHN that was completed more than 6 months before trial entry; 2. Major surgery or irradiation within 4 weeks before trial entry; 3. Previous treatment with monoclonal antibody or signal transduction inhibitors targeting EGFR; 4. Legal incapacity or limited legal capacity; 5. Known allergic reaction against any of the components of the trial treatment; 6. Active infection including active tuberculosis, known and declared human immunodeficiency virus (HIV) infection, or active hepatitis B/C virus (HBV/HCV) infection resulting in an impaired liver function or cirrhosis; 7. History of organ allograft, autologous/allogeneic stem cell transplantation, and renal replacement therapy; 8. Asymptomatic severe hypertension or hypertensive crisis defined as systolic blood pressure 180 mmHg and/or diastolic blood pressure 110 mmHg under resting conditions; 9. Impaired cardiac function, evidenced by any of the following conditions: 1) Left ventricular ejection fraction < 45%; 2) Serious arrhythmia; 3) Unstable angina pectoris; 4) Congestive heart failure New York Heart Association class III or IV; 5) Myocardial infarction within the last 12 months before trial entry; 6) Pericardial effusion; 10. Known central nervous system metastasis and/or leptomeningeal disease. Subjects with neurological symptoms should undergo a CT/MRI of the brain to exclude brain metastasis; 11. Known uncontrolled diabetes mellitus, pulmonary fibrosis, interstitial lung diseases, acute pulmonary diseases, or liver failure; 12. Peripheral neuropathy or hearing loss than Grade 2; 13. Subjects not recovered from any acute effects of prior surgery, chemotherapy, or radiation therapy, that is, to = Grade 1 (CTCAE, version 4.03). Chronic late toxicities resulting from prior radiation and/or surgery (pharyngeal/laryngeal toxicity, i.e. xerostomia, speech, swallowing abnormalities etc.) are permitted if nutritional status is stable; 14. Known alcohol and/or drug abuse; 15. Medical or psychological condition that would not permit the subject to complete the trial or sign informed consent; 16. Past or current history of neoplasm other than SCCHN, except for curatively treated nonmelanoma skin cancer, in situ carcinoma of the cervix, or other cancer curatively treated and with no evidence of disease for at least 5 years; 17. Any investigational medication within 30 days before trial entry; 18. Female subjects who are pregnant (absence to be confirmed by serum ß-human chorionic gonadotropin [HCG] test) or breast feeding, or males and females of reproductive potential not willing or not able to employ a highly effective method of birth control/contraception to prevent pregnancy from 2 weeks before receiving trial treatment until 3 months after receiving the last dose of trial treatment. A highly effective method of contraception is defined as having a low failure rate (< 1% per year) when used consistently and correctly; 19. Concurrent treatment with a prohibited medication; 20. Subjects with any concurrent medical condition or disease that will potentially compromise the conduct of the trial at the discretion of the Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hematology;Radiological examination; | — |
Countries
China
Contacts
Public ContactFeng Wang
West China Hospital, Sichuan University
Outcome results
None listed