Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical efficacy has been shown in adult with head and neck cancer. The study assessed the safety, and efficacy of the combination of Nimotuzumab administered concomitantly with chemotherapy in patients with advanced colorectal cancer.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Experimental: Nimotuzumab and Irinotecan the chemotherapy treatment: Irinotecan (180 mg/m2/time, 1 time/14 days, until disease progression) the nimotuzumab treatment: 3 levels (200 mg/w, 400 mg/w, 600 mg/w, weekly, until disease progression)
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGPeking University, School of Oncology, Beijing Cancer Hospital & Institute
Beijing, China
RECRUITINGChina People's Liberation Army (PLA)81 Hospital
Nanjing, China
NOT_YET_RECRUITINGSafety and toxicity of this new treatment. Both acute and chronic toxicity will be evaluated.
Time frame: within study period
To determine the complete response rate, partial rate, disease response rate, disease control rate in the patients subject to treatment
Time frame: 3 months
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