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Pembrolizumab Plus Chemo in Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma (Eastern Cooperative Thoracic Oncology Projects 2004, ECTOP-2004) — HYPERION  

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:
A Pilot Study of Hypoxia as a Potential Resistance Mechanism to PD-1 Checkpoint Blockade Therapy in Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma (HYPERION)

Clinical Trial Summary

The purpose of this trial is to evaluate efficacy and safety of pembrolizumab plus standard of care (SOC) chemotherapy with cisplatin and paclitaxel as neoadjuvant treatment in participants with locally advanced esophageal squamous cell carcinoma (ESCC), and to explore treatment resistance mechanisms.

Clinical Trial Description

The overall primary efficacy hypotheses are as follows: In all eligible participants with locally advanced ESCC, pathologic complete response (pCR) rate is non-inferior with pembrolizumab plus SOC chemotherapy compared with historical benchmark. The overall primary translational hypotheses are as follows: Major hypoxia signals are significantly higher in baseline or post-treatment tumor samples from non-responders to pembrolizumab plus SOC chemotherapy, as compared to those samples from responders. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05281003
Study type Interventional
Source Fudan University
Contact Haiquan Chen, M.D., Ph.D.
Phone (86)13601973588
Email Hqchen1@yahoo.com
Status Recruiting
Phase Phase 2
Start date February 20, 2023
Completion date September 1, 2026
View Details
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