NCT04888403

Exploring the Safety and Effectiveness of Toripalimab Combined With Neoadjuvant Radiotherapy and Chemotherapy in the Locally Advanced Esophageal Squamous Cell Carcinoma

A Prospective Study on the Safety and Effectiveness of Toripalimab Combined With Neoadjuvant Radiotherapy and Chemotherapy in the Treatment of Locally Advanced Esophageal Squamous Cell Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: The First Affiliated Hospital of Zhengzhou University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to observe and evaluate the efficacy and safety of Toripalimab Combined With Neoadjuvant Radiotherapy and Chemotherapy in the Locally and Advanced Esophageal Squamous Cell Carcinoma

Detailed description

In China, the incidence of esophageal cancer has declined in recent years, but the mortality rate has been ranked fourth. Morbidity and mortality were ranked sixth and fourth in all malignancies, respectively. Therefore, esophageal cancer has always been a major malignant tumor that threatens the health of our residents. Investigator designed a single-arm, open-label, phase II trial of Toripalimab Combined With Neoadjuvant Radiotherapy and Chemotherapy for locally advanced esophageal squamous cell carcinoma. The purpose of this study is to observe and evaluate the efficacy and safety of Toripalimab Combined With Neoadjuvant Radiotherapy and Chemotherapy for locally advanced esophageal squamous cell carcinoma.

Conditions

• Locally Advanced Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Toripalimab+Nedaplatin+Albumin Paclitaxel	Toripalimab 240mg administered intravenously (IV) on Day 1 of each 21-day cycle for 1 cycles. Other Names:Toripalimab+Nedaplatin+Albumin Paclitaxel Neoadjuvant radiotherapy after 2W: The radiotherapy dose is 41.4Gy, completed in 23 times, 5 times a week, using intensity-modulated radiotherapy (IMRT) or volume-modulated radiotherapy (VMAT); In the same period, albumin paclitaxel combined with nedaplatin chemotherapy: albumin paclitaxel 60mg/m2 + nedaplatin 25mg/m2, performed once a week, 5 times in total; Simultaneous immunotherapy: 240 mg of Toripalimab (PD-1 antibody), once every 3 weeks, 4 times in total; Received radical resection of esophageal cancer within 7 weeks after radiotherapy and chemotherapy. Other Names:Toripalimab+Nedaplatin+Albumin Paclitaxel

Timeline

• Start date: 2021-12-31
• Primary completion: 2022-07-20
• Completion: 2022-07-20
• First posted: 2021-05-17
• Last updated: 2021-08-23

Locations

1 site across 1 country: China