Clinical Trial

Pembrolizumab Plus Neoadjuvant Chemotherapy vs. Neoadjuvant Chemoradiotherapy for Locally Advanced ESCC (KEYSTONE-002)

Study acronym: KEYSTONE-002
Recruiting Phase 3
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Record status
This record was last updated June 1, 2022 (before its estimated December 31, 2023 completion). Its status may not reflect the trial's current state.
Summary
The purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus paclitaxel, cisplatin as neoadjuvant therapy followed by surgery, and pembrolizumab as adjuvant therapy, compared with neoadjuvant chemoradiotherapy and surgery for locally advanced ESCC in multicenter.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2021-03-17; most recent amendment 2022-05-26.
Trial Details
NCT Number NCT04807673
Lead Sponsor Tianjin Medical University Cancer Institute and Hospital
Collaborators: Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Shanghai Chest Hospital, Ruijin Hospital, Hebei Medical University Fourth Hospital, Harbin Medical University, Liaoning Cancer Hospital & Institute, Shanxi Province Cancer Hospital, Jining First People's Hospital, Weifang People's Hospital, Tianjin Medical University General Hospital, Shandong Provincial Hospital
Conditions Esophageal Squamous Cell Carcinoma
Enrollment 342 participants
Start Date 2021-12-01
Primary Completion 2023-12-31 (estimated)
Study Completion 2028-05 (estimated)
Updated on ClinicalTrials.gov 2022-06-01