RecruitingPhase 3NCT04807673

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)

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Enrollment

342 participants

Start Date

Dec 1, 2021

Study Type

INTERVENTIONAL

Conditions

Esophageal Squamous Cell Carcinoma

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two pre-surgery treatment approaches for people with locally advanced esophageal squamous cell cancer: standard chemoradiotherapy (chemotherapy plus radiation) versus chemotherapy combined with an immunotherapy drug (pembrolizumab), to determine which better shrinks the tumor before surgical removal. **You may be eligible if...** - You are between 18 and 75 years old - You have esophageal squamous cell carcinoma confirmed by biopsy - Your cancer is in the chest portion of the esophagus and is potentially curable by surgery - Your cancer staging is cT1-3N1-2M0 or cT2-3N0M0 (locally advanced but no distant spread) - You are in good general health (ECOG 0-1) **You may NOT be eligible if...** - Your cancer has spread to distant organs - You have had prior treatment for this cancer - You have severe heart, lung, or immune system problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALPembrolizumab

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.

DRUGPaclitaxel

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

DRUGCisplatin

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

RADIATIONneoadjuvant 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

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