Pembrolizumab in Post Radical Operation ESCC Patients With Lymph Node Positive ( KEYSTONE-004 )

Pembrolizumab Clinical Trial

Official title: Pembrolizumab for Adjuvant Treatment After R0 Resection of Thoracic ESCC Patients With Lymph Node Positive: A Single-arm, Open-label, PhaseⅡTrial

Status Recruiting

Clinical Trial Summary

The purpose of this study is to observe and evaluate the efficacy and safety of postoperative adjuvant treatment of pembrolizumab in patients with thoracic esophageal squamous cell carcinoma （ESCC） who have not received neoadjuvant therapy before undergoing R0 resection, and have positive postoperative lymph nodes.

Clinical Trial Description

For patients with thoracic esophageal squamous cell carcinoma （ESCC） who have undergone R0 resection, have not received neoadjuvant therapy, and have positive postoperative lymph nodes, there is no international consensus on whether postoperative adjuvant therapy is required. The JCOG9204 study reported that for patients with ESCC with positive lymph nodes after R0 resection, postoperative adjuvant chemotherapy can improve the disease-free survival (DFS) of the ESCC patients. However, due to the adverse effects of chemotherapy, patients are often difficult to tolerate. We designed a single-arm, open-label, phase II trial of pembrolizumab for adjuvant treatment after R0 resection of thoracic ESCC Patients with lymph node positive. The purpose of this study is to observe and evaluate the efficacy and safety. ;

Related Conditions & MeSH terms

• ESCC
• Pembrolizumab

• NCT number: NCT04863079
• Study type: Interventional
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Hongjing Jiang, MD, PhD
• Phone: +8618622221069
• Email: jianghongjing@tmu.edu.cn
• Status: Recruiting
• Phase: Phase 2
• Start date: May 1, 2021
• Completion date: April 30, 2024