A Prospective, Single Arm, Multicenter, Phase II Study of Nimotuzumab in Combination With Neoadjuvant Chemotherapy for Resectable Esophageal Squamous Cell Carcinoma
A surgical resection is currently the preferred treatment for esophageal cancer if the tumor
is considered to be resectable without evidence of distant metastases. A higher percentage
of radical resection is reported in studies using neoadjuvant chemotherapy followed by
surgery versus surgery alone. The neoadjuvant chemotherapy may improve overall survival.
Neoadjuvant chemotherapy with administrations of paclitaxel combined with cisplatin or
carboplatin has shown effectively. Nimotuzumab is a humanized monoclonal antibody against
epidermal growth factor receptor (EGFR). The clinical phase I study of the combination of
Nimotuzumab administered concurrently with chemo-irradiation in patients with local advanced
esophageal squamous cell carcinoma has shown the safety and the potential efficacy of
Nimotuzumab. The concurrent trial is a clinical phase II trial designed to assess the
efficacy of the combination of Nimotuzumab administered concurrently with neoadjuvant
chemotherapy in patients with resectable Esophageal Squamous Cell Carcinoma, and to further
investigate its side-effect and toxicity.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Pathology complete remission rate
Pathology complete remission rate is the primary outcome measure.
China: Ministry of Health