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RECRUITING
NCT04807673
PHASE3

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

Sponsor: Tianjin Medical University Cancer Institute and Hospital

View on ClinicalTrials.gov

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.

Official title: A Multicenter Randomized, Controlled Phase III Clinical Trial of Pembrolizumab Plus Paclitaxel and Cisplatin Versus Neoadjuvant Chemoradiotherapy Followed by Surgery for Locally Advanced Esophageal Squamous Cell Carcinoma (KEYSTONE-002)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

342

Start Date

2021-12-01

Completion Date

2028-05

Last Updated

2022-06-01

Healthy Volunteers

No

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

Locations (1)

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

Tianjin, Tianjin Municipality, China