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
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
200,400,600 or 800mg weekly until progression or AEs
180mg/m2 d1, Q2w until progression or AEs or maximum 6 cycles
China People's Liberation Army (PLA)81 Hospital
Nanjing, Jiangsu, China
Peking University, School of Oncology, Beijing Cancer Hospital & Institute
Beijing, China
The rate of grade 3/4 toxicity
The rate of grade 3/4 toxicity, defined as the proportion or frequency of patients who experience toxicity reactions that are classified as grade 3 or grade 4 according to CTCAE v5.0.
Time frame: 3 months
Maximum Tolerated Dose (MTD)
Rate of dose-limiting toxicities (DLTs) after infusion of nimotuzumab. The highest dose at which 0 or 1 DLT occurs in 6 DLT-evaluable subjects will be declared the maximum tolerated dose (MTD).
Time frame: 3 months
The complete response rate
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT/MRI: Complete Response (CR), defined as the disappearance of all target lesions.
Time frame: 3 months
The partial response rate
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT/MRI: Partial Response (PR), defined as at least a 30% decrease in the sum of the longest diameter of target lesions.
Time frame: 3 months
The disease control rate
Disease control rate (DCR), including complete response (CR) and partial response (PR) and stable disease(SD). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT/MRI: CR, disappearance of all target lesions; PR, at least a 30% decrease in the sum of the longest diameter of target lesions. SD, neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (PD, defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions).
Time frame: 3 months
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