Nimotuzumab Combined With Neoadjuvant Chemotherapy in the Treatment of Resectable LA HNSCC
Status:
Not yet recruiting
Trial end date:
2024-07-30
Target enrollment:
Participant gender:
Summary
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.