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

Study acronym: KEYSTONE-002
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
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.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: May 2023 to Dec 31, 2023
    • Start date changed from estimate of May 2021 to Dec 1, 2021
    • Site contact updated
    • Collaborators: 12 to 11
    v3
  2. Eligibility criteria shortened, about 1 wordv2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
(from sponsor)		 Esophageal Squamous Cell Carcinoma
Related terms Esophageal Squamous Cell Carcinoma
Enrollment 342 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov