NCT04807673

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

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 342 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Preoperative chemoradiotherapy with radical surgery is the recommended treatment for locally advanced esophageal squamous cell carcinoma (ESCC) in the NCCN guidelines. But many patients refused or abandon radiotherapy because of the intolerable adverse effects. 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. The primary study hypothesis is that Event Free Survival (EFS) is superior with pembrolizumab plus neoadjuvant chemotherapy compared with neoadjuvant chemoradiotherapy in participants with ESCC.

Conditions

• Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-12-01
• Primary completion: 2023-12-31
• Completion: 2028-05-01
• First posted: 2021-03-19
• Last updated: 2022-06-01

Locations

1 site across 1 country: China