Advanced head and neck squamous cell carcinoma in Baotou
Conditions
Interventions
Experimental group:Nimotuzumab plus concurrent radiotherapy
Sponsors
Baotou Tumor Hospital
Eligibility
Sex/Gender
All
Age
65 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 65-80 years old, including 65 and 80 years old; 2. ECOG PS score 0-2; 3. Stage III - IV B squamous cell carcinoma of head and neck (including oral cancer, oropharyngeal cancer, hypopharyngeal cancer, laryngeal cancer, and unexplained metastatic squamous cell carcinoma of neck, except nasopharyngeal carcinoma) diagnosed by histopathology or cytology (according to the 2020 CSCO guidelines for the diagnosis and treatment of head and neck tumors); 4. Immunohistochemical detection of histopathology showed positive expression of EGFR; 5. Patients who are not suitable for surgery (defined as patients whose physical conditions do not allow or refuse surgery for various reasons); 6. According to RECIST version 1.1 evaluation criteria, there is at least one measurable lesion; 7. Suitable for radical radiotherapy and chemotherapy; 8. Expected survival time >= 3 months; 9. Hematological indexes were basically normal: leukocyte count >=4*10^9/L Absolute neutrophil count >=1.5* 10^9/L; Platelet >=100*10^9/L; Hemoglobin >= 90g/L; 10. Renal function was basically normal: serum creatinine = 60ml / min 11. Liver function is basically normal: serum total bilirubin <= 1.5*ULN (if there is liver metastasis, the total serum bilirubin should be <= 3.0*ULN) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5*ULN(<=5.0*ULN, if there is liver metastasis); 12. Sign written informed consent.
Exclusion criteria
Exclusion criteria: 1. Those who have received radiotherapy, chemotherapy, monoclonal antibody, oral EGFR-TKI treatment, anti-angiogenesis drugs, and immunosuppressants within half a year; 2. Participated in other intervention clinical trials within 30 days before screening; 3. Patients with distant metastasis; 4. History of other malignant tumors (except cured cervical carcinoma in situ or skin basal cell carcinoma and other malignant tumors that have been cured for more than 5 years); 5. there are concurrent diseases with poor control (such as heart failure, diabetes, hypertension, thyroid disease, mental illness, etc.); 6. Known to be infected with HIV or active viral hepatitis; 7. Being treated with chronic steroids for more than 6 months (e.g. prednisone dose > 10 mg/day or equivalent); 8. Those who are allergic to the drugs or their components used in this protocol; 9. According to the standard of common adverse event terminology (NCI CTCAE V5.0), >= grade 2 peripheral nerve disease or hearing loss; 10. The researcher believes that it is not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective remission rate(ORR);Total tumor response rate(CRR);Disease Control rate;2 year total survival (OS) rate;Local control rate for 2 years;Medina progression-free survival(PFS);Living quality; | — |
Contacts
Public ContactKong Xianghu
Baotou Tumor Hospital
Outcome results
None listed