Toripalimab With Paclitaxel and Cisplatin as Neoadjuvant Treatment for Esophageal Squamous Cell Carcinoma
Status:
Recruiting
Trial end date:
2024-03-01
Target enrollment:
Participant gender:
Summary
Neoadjuvant chemoradiotherapy or chemotherapy followed by surgery is the standard treatment
for local advanced esophageal cancer (EC). It had been demonstrated that patients who achieve
pathologic complete response (pCR) after neoadjuvant treatment had better prognosis. However,
the pCR rate were about only 5-10% in neoadjuvant chemotherapy and 20-40% in neoadjuvant
concurrent chemoradiotherapy.
PD-1 antibody based immunotherapy alone as second-line treatment or combined with
chemotherapy as first-line treatment had been proved that could prolong overall survival of
EC patients. And a recent phase 3 clinical trial CheckMate 577 reported that, as adjuvant
treatment, nivolumab could improve disease-free survival in EC and esophageal-gastric
junction cancer.
The aim of this study was to evaluate the efficacy and safety of toripalimab, an anti-PD-1
antibody, combined with paclitaxel and cisplatin as neoadjuvant treatment in local advanced
esophageal squamous cell carcinoma (ESCC). We hope this combining treatment would increase
the pCR rate of neoadjuvant chemotherapy and improve survival of patients, and at the
menatime avoid the adverse events of neoadjuvant radiotherapy. This study will provide
valuable information for further clinical trials of both Toripalimab and other immune
checkpoint inhibition agents in treatment of esophageal cancer.