Neoadjuvant Treatment of Nimotuzumab With Chemotherapy or Radiotherapy in Resectable Esophageal Squamous Cell Carcinoma
Status:
Withdrawn
Trial end date:
2020-12-01
Target enrollment:
Participant gender:
Summary
Esophageal cancer is one of common malignant tumors in China and esophageal squamous cell
carcinoma (ESCC) is the dominant pathological type, accounting for more than 95% of all
cases. One of our phase Ⅱ study introduced a combination treatment of an anti epithelial
growth factor receptor (EGFR) agent, nimotuzumab, with paclitaxel and cisplatin as first-line
treatment in unresectable or metastatic ESCC. The results showed that the overall response
rate was 51.8% (29/56) and disease control rate was 92.9% (52/56). As a median follow-up of
24 months, the median progression-free survival for patients with metastatic disease and
local advanced disease were 8.2 months and more than 23 months respectively. The overall
survival for patients with metastatic disease was 13.9 months. It implied that as first-line
chemotherapy, an addition of nimotuzumab to chemotherapy was a more active treatment option
compared to other regimens published in previous studies. Investigations by Liang, J. and
Ling, Y. also suggested that nimotuzumab in combining with radiotherapy or chemotherapy also
showed anti-tumor activities and limited toxicities.
Therefore, we initiated this phase Ⅱ to Ⅲ clinical trial in which combining neoadjuvant
treatments of nimotuzumab with chemotherapy or nimotuzumab with radiotherapy are compared
with surgery alone for resectable stage Ⅱa to Ⅲ middle and lower thoracic esophageal squamous
cell carcinoma patients. We hope to explore if these neoadjuvant combination treatments could
bring survival benefit for ESCC patients.