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 head and neck cancer. The phase II study assessed the efficacy and safety of the combination of Nimotuzumab administered concomitantly with radiotherapy in patients with esophageal cancer tumours.
Clinical efficacy has been shown in adult with head and neck cancer. The phase II study assessed the efficacy and safety of the combination of Nimotuzumab administered concomitantly with radiotherapy in patients with esophageal cancer tumours.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
the nimotuzumab treatment; 200mg/w,weekly,5-6 weeks.
the Radiotherapy treatment;95%PTV A dose of 50-60Gy will be administered in 25-30 fractions ( 2 Gy /fraction)
The Affiliated tumour hosiptal of HARBIN Medical University
Harbin, Heilongjiang, China
Wuhan Union Hospital
Wuhan, Hubei, China
Qilu Hospital,Shandong University
Jinan, Shandong, China
Cancer Institute & Hospital, Chinese Academy of Medical Sciences
Beijing, China
The rate of AE(adverse event) or toxicity ( Both acute and chronic toxicity will be evaluated.)
assement of advers event after using medication based TAAE evaluation form
Time frame: 3 months
Complete response
Time frame: 3 months
Partial response (PR)
Time frame: 3 months
Stable disease (SD)
Time frame: 3 months
Progressive disease (PD)
Time frame: 3 months
Median survival time (MST)
Time frame: 2 years
Overall survival (OS)
Time frame: 1 year,2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China