RecruitingPhase 2NCT06354218

Serplulimab Combined With Concurrent Chemoradiotherapy for Locally Advanced Treatment Esophageal Cancer in Old Age

A Single Arm, Prospective, Exploratory, Single Center Phase II Clinical Study of Serplulimab Combined With Synchronous Radiochemotherapy for the Treatment of Locally Advanced Esophageal Squamous Cell Cancer in Elderly Patients With Non Surgical Resectable Lesions Research Plan


Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

50 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a Single Arm, Prospective, Exploratory, Single Center Phase II Clinical Study to evaluate the effectiveness of the combination of Serplulimab and Concurrent Chemoradiotherapy in the treatment of elderly patients with locally advanced esophageal cancer who cannot be treated surgically.Subjects can be enrolled into this study only if they meet inclusion criteria and do not meet exclusion criteria.


Eligibility

Min Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding an immunotherapy drug (serplulimab) to standard combined chemotherapy and radiation treatment improves outcomes for elderly patients (75 and older) with locally advanced esophageal cancer that cannot be surgically removed. **You may be eligible if...** - You are 75 years of age or older with confirmed esophageal squamous cell carcinoma, Stage II–IVa - Your cancer cannot be surgically removed (due to location, health, or personal choice) - Your tumor shows a PD-L1 score (CPS) of 1 or higher - You have not received any prior cancer treatment - You are in good general health (ECOG score 0 or 1) with an expected survival of at least 3 months **You may NOT be eligible if...** - You are under 75 years old - Your tumor has already been treated with any systemic therapy, radiation, or targeted drugs - You have had another cancer in recent years - Your organ function (kidneys, liver, blood counts) is not adequate for treatment 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

DRUGSerplulimab

Serplulimab (4.5mg/Kg every 3 weeks)


Locations(1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

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NCT06354218


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