Squamous cell carcinoma of head and neck
Conditions
Interventions
Group 1:Nimotuzumab combined with radiotherapy / chemoradiotherapy
Group 2:Received radiotherapy / chemoradiotherapy but not nituzumab
Sponsors
Department of Head and Neck Surgery, Baotou Cancer Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects over 18 years old; 2. Subjects with ECoG PS score of 0-2; 3. Patients with stage III - IV B head and neck squamous cell carcinoma (except nasopharyngeal carcinoma) confirmed by histopathology or cytology (according to the 2020 CSCO guidelines for diagnosis and treatment of head and neck cancer); 4. According to RECIST version 1.4; 5. Patients receiving radiotherapy or chemoradiotherapy, or patients receiving nimotuzumab on the basis of radiotherapy / chemoradiotherapy; 6. Female patients must have negative urine pregnancy test before the start of the study (not applicable to patients with bilateral ovariectomy and / or hysterectomy or postmenopausal patients); 7. The subjects with good compliance signed the written informed consent.
Exclusion criteria
Exclusion criteria: 1. Subjects who had received radiotherapy, chemotherapy, monoclonal antibody, oral EGFR-TKI, antiangiogenic drugs and immunosuppressants within half a year; 2. Select the subjects who have participated in other intervention clinical trials in the first 30 days; 3. Patients with primary malignant tumors other than head and neck tumors (except for cured skin basal cell carcinoma and cervical carcinoma in situ); 4. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| total survival (OS) rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Medina progression-free survival (PFS);Local control rate;Total tumor response rate (CRR);Objective remission rate (ORR);Disease Control rate;living quality; | — |
Countries
China
Contacts
Public ContactHan Bo
Baotou Cancer Hospital
Outcome results
None listed