drugset / Trial / NCT01899118

Nimotuzumab in Combination With Chemoradiation in Patients With Locally Advanced Rectal Cancer

NCT01899118

Phase 2 Unknown 50 enrolled Zhejiang Cancer Hospital
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2013-04
Primary completion
2016-04
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 825 mg/m2
Subject Nimotuzumab Monoclonal antibody 400 mg
Subject Oxaliplatin Small molecule 130 mg/m2

Indications

No indication recorded.