This study is a prospective, open-label, single-arm study. The trial will be divided into 3 phases: screening/baseline, treatment and follow-up. To initially explore the efficacy and safety of nimotuzumab combined with neoadjuvant chemotherapy (TPF regimen) in the treatment of resectable locally advanced head and neck tumors. Targeted therapy: Nimotuzumab injection 400 mg, once on the 1st day and once on the 21st day, for a total of 2 times. It should be administered by intravenous infusion 1 hour before chemotherapy, and the administration process should last for more than 60 minutes. Chemotherapy (TPF regimen): nab-paclitaxel 175mg/m2, on the 1st day; nedaplatin 100mg/m2, on the 1st day; oral administration of Sigirone on the 1st-14th day, 2/day; a treatment cycle of 21 days, a total of 2 a treatment cycle. After two cycles of chemotherapy, all patients underwent radical surgery according to whether the throat could be preserved and the patient's own wishes. The primary endpoint of the study is the tumor objective response rate (ORR), and the secondary endpoints are the primary tumor pathological complete response (pCR) rate, organ preservation rate, 1-year overall survival (OS) rate, and 1-year disease-free survival (DFS) rate. , quality of life, safety evaluation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
The study arm received nimotuzumab (400mg, every three weeks, for 2 weeks) combined with TPF chemotherapy
Objective Response Rate (ORR)
Time frame: 1 year
Primary pathological complete response rate (pCR)
Time frame: 1 year
R0 resection rate
Time frame: 1 year
Organ retention rate
Time frame: 1 year
Overall survival (OS)
Time frame: 1 year
Disease free survival (DFS)
Time frame: 1 year
Quality of life assessed by EORTC QLQ-H&N35
Quality of life assessed by EORTC QLQ-H\&N35 \[EORTC QLQ-H\&N35 is a specific quality of life assessment scale based on EORTC QLQ-C 30, with 35 items. All of the scales and single-item measures range from 0 to 100. A high score represents a higher response level.\]
Time frame: 1 year
Incidence of treatment-emergent adverse events
Time frame: 1 year
The change of tumor related markers
The correlation of the value of EGFR, SCC-Ag, CEA and therapeutic effect \[The changes of serum tumor markers (such as SCC-Ag and CEA were observed before and after treatment. The baseline EGFR levels on the prognosis of patients should also be explored\]
Time frame: 1 year
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