A Randomized Phase II Trial Evaluating The Addition Of Nimotuzumab To Chemoradiation For Patients With Esophageal Squamous Cell Carcinoma After Radical Esophagectomy Who Suffer With Lymph Nodes Recurrence
Esophageal squamous cell carcinoma after radical esophagectomy, then recurrent with lymph
nodes in bilateral supravascular fossa or upper mediastinum 6 months beyond esophagectomy.
Eligible recurrent patients with esophageal cancer will first be stratified by recurrent
time after esophagectomy (within 2 years after esophagectomy, or beyond 2 years after
esophagectomy), then randomized to 2 arms at 1:1 ratio.
Chemoradiation + weekly Nimotuzumab for 6 weeks concurrent with radiation.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate if the addition of nimotuzumab to chemoradiation improves local control compared to chemoradiation only in patients with esophageal squamous cell carcinoma after radical esophagectomy who recurrent in regional lymph nodes.
Xiao-Long Fu, M.D, Ph.D.
People's Republic of China: State Food and Drug Administration