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

PHASE3RecruitingINTERVENTIONAL
Enrollment

342

Participants

Timeline

Start Date

December 1, 2021

Primary Completion Date

December 31, 2023

Study Completion Date

May 31, 2028

Conditions
Esophageal Squamous Cell Carcinoma
Interventions
BIOLOGICAL

Pembrolizumab

"Neoadjuvant period: pembrolizumab 200mg IV D1, Q3W, and preoperative therapy with three cycles.~Adjuvant period: pembrolizumab 200 mg IV D1, Q3W, up to one year, which should be performed within 3-6 weeks after surgery."

DRUG

Paclitaxel

Neoadjuvant period: paclitaxel 135mg/m\^2 IV on Day 2 Q3W, and a total of three cycles.

DRUG

Cisplatin

Neoadjuvant period: cisplatin 80 mg/m\^2 IV on Day 2 Q3W, and a total of three cycles.

RADIATION

neoadjuvant chemoradiotherapy

neoadjuvant chemoradiotherapy 41.4Gy(1.8Gy×23 fractions) with five cycles of TP(Paclitaxel 50mg/m\^2 on D1 and Cisplatin 25mg/m\^2 D1, repeated every week

Trial Locations (1)

300060

RECRUITING

Department of minimally invasive esophageal surgery, Tianjin Medical University Cancer Institute and Hospital, Tianjin

All Listed Sponsors
collaborator

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

collaborator

Shanghai Chest Hospital

OTHER

collaborator

Ruijin Hospital

OTHER

collaborator

Hebei Medical University Fourth Hospital

OTHER

collaborator

Harbin Medical University

OTHER

collaborator

Liaoning Cancer Hospital & Institute

OTHER

collaborator

Shanxi Province Cancer Hospital

OTHER

collaborator

Jining First People's Hospital

OTHER

collaborator

Weifang People's Hospital

OTHER

collaborator

Tianjin Medical University General Hospital

OTHER

collaborator

Shandong Provincial Hospital

OTHER_GOV

lead

Tianjin Medical University Cancer Institute and Hospital

OTHER