NCT04804696

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Esophageal Squamous Cell Cancer

Interventions

Type	Name	Description
DRUG	Toripalimab	Patients received toripalimab 240 mg I.V. drip on days 1 and 22.
DRUG	Paclitaxel	Patients received paclitaxel of 175mg/m2 I.V. drip on days 1 and 22.
DRUG	Cisplatin	Patients received cisplatin of 70mg/m2 I.V. drip on days 1 and 22.

Timeline

• Start date: 2021-02-10
• Primary completion: 2024-11-29
• Completion: 2024-11-29
• First posted: 2021-03-18
• Last updated: 2025-02-21

Locations

1 site across 1 country: China