Neoadjuvant camrelizumab combined with chemoradiotherapy and watch-and-wait strategy versus neoadjuvant chemoradiotherapy followed by surgery in locally advanced oesophageal squamous cell carcinoma: study protocol of a randomised controlled trial (PALACE-3).

ABSTRACT:

Introduction

Combining immunotherapy with neoadjuvant chemoradiotherapy (neoCRT) has been shown to be safe, achieving a pathological complete response (pCR) rate of 56% in patients with locally advanced oesophageal squamous cell carcinoma (ESCC) in the PALACE-1 trial. This high pCR rate encourages us to explore the feasibility of postponing surgery after immunotherapy combined with neoCRT under active surveillance. This study aims to assess the efficacy, safety and patient-reported quality of life (QOL) of camrelizumab combined with neoCRT and watch-and-wait strategy versus neoCRT followed by surgery in locally advanced resectable ESCC.

Methods and analysis

The PALACE-3 trial is a multicentre, open-label, randomised non-inferiority trial expected to recruit 356 patients from

SUBMITTER: Wang X 

PROVIDER: S-EPMC12530390 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature