Phase IIa Study of Nimotuzumab Plus Irinotecan as Second-line Treatment in Metastatic Colorectal Cancer With Wild Type K-ras
Nimotuzumab and Irinotecan will be administered to the patient until disease progression or
development of toxicity preclude further treatment.Irinotecan will be administered once
every 14 days,the dosage is 180mg/m2; Nimotuzumab treatment be divided 3
levels:200mg/w,400mg/w,600mg/w,weekly.The patients'blood test and liver and renal function
tests will be monitored weekly, a physical exam and reassessment of the tumor will be
performed and every 6 weeks,when the total result is the CR or PR, the result of the 6th and
the 12th week should be compared.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety and toxicity of this new treatment. Both acute and chronic toxicity will be evaluated.
within study period
Department of GI Oncology,Peking University, School of Oncology, Beijing Cancer Hospital & Institute
China: Food and Drug Administration