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

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.

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

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  collaborator OTHER

• Shanghai Chest Hospital

  collaborator OTHER

• Ruijin Hospital

  collaborator OTHER

• Hebei Medical University Fourth Hospital

  collaborator OTHER

• Harbin Medical University

  collaborator OTHER

• Liaoning Cancer Hospital & Institute

  collaborator OTHER

• Shanxi Province Cancer Hospital

  collaborator OTHER

• Jining First People's Hospital

  collaborator OTHER

• Weifang People's Hospital

  collaborator OTHER

• Tianjin Medical University General Hospital

  collaborator OTHER

• Shandong Provincial Hospital

  collaborator OTHER_GOV

• Tianjin Medical University Cancer Institute and Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-12-01

Primary Completion

2023-12-31

Completion

2028-05-31

Countries

• China

Study Locations