The aim of the study is to evaluate the role of nimotuzumab in the neo-adjuvant setting in patients with locally advanced HNSCC. The hypothesis is that the response would be increased with the combination of nimotuzumab and cisplatin and fluorouracil (PF) regimen.
Induction chemotherapy followed by radiotherapy is the standard treatment for patients with unresectable HNSCC. However, the role of induction chemotherapy remains uncertain for resectable disease. Therefore, we plan to perform a phase II study to evaluate it, focusing on radiographic and pathologic response after induction chemotherapy. Moreover, a new EGFR monoclonal antibody (nimotuzumab) is incorporated with PF regimen. The hypothesis is the addition of nimotuzumab would improve the response without remarkably increase the toxicity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
nimotuzumab 400 mg d1
cisplatin 75 mg/m2 d1 and 5-FU 750 mg/m2/d CIV d1-5
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China
overall response rate
Time frame: 6 weeks
pathologic complete response
Time frame: 8 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.