The phase II study is performed to assess the efficacy and safety of Nimotuzumab in patients with stage IV pancreatic neuroendocrine neoplasms and EGFR overexpression.
Nimotuzumab (hR3) 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 various types of cancer with EGFR overexpression. The phase II study is performed to assess the efficacy and safety of Nimotuzumab in patients with stage IV pancreatic neuroendocrine neoplasms and EGFR overexpression.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
nimotuzumab 200mg/week
Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
Shanghai, Shanghai Municipality, China
Overall response rate (ORR)
Overall Response rate was defined as the proportion of patients with a best overall response of complete response or partial response, based on investigator's assessment as per RECIST criteria version 1.1.
Time frame: Baseline to 6 months
Disease control rate (DCR)
Disease control rate was defined as the proportion of patients with a best overall response of Complete Response, Partial response, or Stable disease, based on the investigator's assessment per RECIST version 1.1.
Time frame: Baseline to 6 months
Progression free survival (PFS)
Time frame: Patients will be followed until disease progression, estimating around 12months
Overall survival (OS)
Time frame: Patients will be followed until disease progression, estimating around 12months
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