drugset / Trial / NCT04807673
Pembrolizumab Plus Neoadjuvant Chemotherapy vs. Neoadjuvant Chemoradiotherapy for Locally Advanced ESCC (KEYSTONE-002)
Phase 3
Recruiting
342 enrolled
Tianjin Medical University Cancer Institute and Hospital
Cancer Institute and Hospital, Chinese Academy of Medical Sciences · collabHarbin Medical University · collabHebei Medical University Fourth Hospital · collabJining First People's Hospital · collabLiaoning Cancer Hospital & Institute · collabRuijin Hospital · collabShandong Provincial Hospital · collabShanghai Chest Hospital · collabShanxi Province Cancer Hospital · collabTianjin Medical University General Hospital · collabWeifang People's Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2021-12-01
- Primary completion
- 2023-12-31
- Completion
- 2028-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 80 mg/m2 | Intravenous |
| Subject | Paclitaxel | Small molecule | 135 mg/m2 | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |