RecruitingPhase 2NCT05281003

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

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)


Sponsor

Fudan University

Enrollment

128 participants

Start Date

Feb 20, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding pembrolizumab (an immunotherapy drug) to standard chemotherapy before surgery improves outcomes for people with locally advanced esophageal squamous cell carcinoma — a cancer in the tube connecting the throat to the stomach. This is called neoadjuvant (pre-surgery) treatment. **You may be eligible if...** - You are 18 or older with locally advanced esophageal squamous cell carcinoma that can be surgically removed - You have not previously received any treatment for this cancer - Your overall health is good (ECOG performance status 0 or 1) **You may NOT be eligible if...** - You have previously received immunotherapy (anti-PD-1 or PD-L1 agents) - You have active autoimmune disease requiring systemic treatment - You have a history of severe lung inflammation (pneumonitis) - You have an active infection requiring treatment - You are pregnant or breastfeeding - You have had an organ transplant 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

DRUGPembrolizumab

Biological: Pembrolizumab 200 mg administered IV Q3W on Day 1 of each 3-week cycle, up to 4 administrations in neoadjuvant setting.

DRUGPaclitaxel

Drug: Paclitaxel 150 mg/m\^2 administered IV Q3W on Day 1 of each 3-week cycle, up to 4 administrations in neoadjuvant setting.

DRUGCisplatin

Drug: Cisplatin 80 mg/m\^2 administered IV Q3W on Day 1 of each 3-week cycle, up to 4 administrations in neoadjuvant setting.


Locations(2)

Fudan University Cancer Center

Shanghai, Shanghai Municipality, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

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NCT05281003


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