Head and Neck Malignancies
Conditions
Interventions
single arm:Nituzumab plus chemotherapy
Sponsors
The Second Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) age 18-75 years, including 18 and 75 years; 2) ECOG score 0-1; 3) patients with distant metastasis and/or recurrence of head and neck squamous cell carcinoma (including oral cancer, oropharyngeal cancer, hypopharyngeal cancer and laryngeal cancer, except nasopharyngeal cancer) diagnosed by histopathology or cytology; 4) unable to perform local treatment (including radiotherapy and surgery); 5) according to RECIST 1.1 evaluation criteria, at least one measurable lesion was found; 6) expected survival period 6 months; 7) upper limit of serum AST, ALT and ALP 2.5 times of normal value (ULN), AST and ALT 5 times of ULN in patients with liver metastasis; Total bilirubin 2 times ULN, liver metastasis 3 times ULN; WBC count 4 x10^9/L; Absolute count of granulocytes 1.5x10^9/L; blood planet=100x10^9/L Hemoglobin 90 g/L; Serum creatinine 1.2mg/dL or creatinine clearance 60mL/min; 8) sign the written informed consent.
Exclusion criteria
Exclusion criteria: 1) received radiotherapy, chemotherapy, monoclonal antibody and oral egfr-tki therapy within three months; 2) participated in other clinical trials within 30 days before screening; 3) have a history of other malignancies (except those cured of carcinoma in situ of the cervix or basal cell carcinoma of the skin and other malignancies cured for more than 5 years); 4) accompanied by other serious diseases; 5) uncontrolled congestive heart failure (NYHA grade III or IV), unstable angina, poorly controlled arrhythmias, and uncontrolled moderate or above hypertension (SBP>160mmHg or DBP>100mmHg); 6) active infection; 7) uncontrollable diabetes (refers to the high fluctuation of blood glucose, the impact on patients' life and the frequent occurrence of hypotension despite the standard insulin treatment and frequent blood glucose monitoring); 8) mental illness affecting informed consent and/or programme compliance; 9) suffering from immune deficiency disease (acquired or congenital); 10) is receiving chronic steroid hormone therapy for more than 6 months (e.g. prednisone dose > 10 mg/ day or equivalent); 11) those who are allergic to the drug or its components used in the program; 12) until at least 6 months after the last trial treatment, subjects will be unwilling or unable to take effective contraceptive measures (for both male and female subjects) until pregnancy (confirmed by HCG test in menstrual blood or urine) or lactating women, or during the child-bearing period; 13) the investigator considers it inappropriate to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| EGFR expression level in tumor tissues;Mutation of k-ras gene;P16 gene expression;HPV gene expression;TGF- 1 in plasma;OS;PFS;ORR;DCR;SAE; | — |
Countries
China
Contacts
Public ContactLiu Ping
Outcome results
None listed