Neoadjuvant (preoperative) concomitant chemoradiotherapy (CRT) is now considered as a standard treatment of locally advanced rectal adenocarcinomas, which correlates better local control and higher sphincter preservation rate. Nimotuzumab, a humanized monoclonal antibody against epidermal growth factor receptor (EGFR) has been reported to improve the therapeutic effect of radiotherapy in some cancers. This study is a clinical phase II trial designed to evaluate the efficacy of the combination of Nimotuzumab administered concurrently with neoadjuvant chemoradiotherapy in patients with locally advanced rectal cancer, and to further investigate its side-effect and toxicity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
50.4Gy/28F/5.5w
400mg/w,0-5w
130mg/m2 d1
825mg/m2 bid d1-5/w,1-5w
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
RECRUITINGPathology complete remission rate
Pathology complete remission rate is the primary outcome measure.
Time frame: 1 year
tumor regression rate
Time frame: 1 year
local recurrence rate
Time frame: 5 years
overall survival
Time frame: 5 years
sphincter preservation rate
Time frame: 3 years
Incidence of Adverse Events
Time frame: up to 1 month after the last cycle
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.