Toripalimab with Paclitaxel and Cisplatin As Neoadjuvant Treatment for Esophageal Squamous Cell Carcinoma

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.

Timeline

Start

2021-02-10

Primary completion

2024-11-29

Completion

2024-11-29

Outcome

Outcome not reported

Stopped: “Several clinical trials had showed that anti-PD-1 agents combined with chemotherapy as neoadjuvant treatment could increase pCR rate in 2024. In order to protect the interest of patients, this trial was stopted.”

Drugs

Indications