Induction Chemotherapy With Nimotuzumab in Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)

Phase II Study of Nimotuzumab Plus PF as Induction Chemotherapy in Patients With Locally Advanced HNSCC

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.

Inclusion Criteria:

• Age range 18-70 years old
• ECOG performance status 0-1
• Histologically confirmed and potentially resectable locally advanced (T2-4, N0-3, M0) HNSCC
• Adequate organ function

Exclusion Criteria:

• History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
• Pregnant or lactating women
• Serious uncontrolled diseases and intercurrent infection
• Previous serious cardiac disease