Spots Global Cancer Trial Database for Pembrolizumab Plus Chemo in Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma (Eastern Cooperative Thoracic Oncology Projects 2004, ECTOP-2004)

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Trial Identification

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

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)

Study ID: NCT05281003

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Pembrolizumab

Paclitaxel

Cisplatin

Study Description

Brief 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.

Detailed 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.