Prospective, Randomized, Controlled, Phase II,Multiple Centered Clinical Trial of Nimotuzumab Combined With Radiotherapy for Senile Locally Advanced SCCHN
condition: Senile Locally Advanced SCCHN. Intervention: Drug:Nimotuzumab. Arm A:
Radiotherapy+Nimotuzumab; Arm B: Radiotherapy alone. Phase: Phase 2
Interventional
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate: complete response + partial response on RECIST evaluation system
1-month after treatment
No
Sun Yan, MD
Principal Investigator
Peking University, School of Oncology, Beijing Cancer Hospital & Institute
China: Food and Drug Administration
BT-IST-SCCHN-040
NCT01393184
March 2011
March 2013
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