RecruitingPhase 2NCT06988956

Nimotuzumab Plus Definite Chemoradiotherapy(dCRT) in Elderly Patients With Esophageal Squamous Cell Carcinoma

A Prospective, Randomized Controlled, Open Label, Multicenter, Phase II Clinical Study Evaluating the Efficacy and Safety of Nimotuzumab Combined With Concurrent Chemoradiotherapy in Elderly Patients With Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma


Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

95 participants

Start Date

Mar 31, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

investigators plan to conduct a multicenter, prospective, randomized controlled, open, phase clinical study to compare the efficacy and safety of nimotuzumab with concurrent chemoradiation alone in elderly participants with advanced esophageal squamous cell carcinoma.


Eligibility

Min Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a drug called nimotuzumab (an antibody that targets cancer cell growth) to standard chemotherapy plus radiation improves outcomes in elderly patients with esophageal squamous cell carcinoma (a type of cancer in the food pipe). **You may be eligible if...** - You are 70 or older - You have been diagnosed with esophageal squamous cell carcinoma (confirmed by biopsy) - Your cancer is stage II–IVB (limited spread, no distant organ metastases other than certain lymph nodes) - Your ECOG performance score is 0–1 (meaning you are generally active and functional) - You have at least one measurable tumor - You are able to tolerate chemotherapy and radiation together **You may NOT be eligible if...** - You are under 70 - Your cancer has spread to distant organs beyond qualifying lymph node sites - Your overall health does not allow you to tolerate combination 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

DRUGNimotuzumab

Nimotuzumab 400mg

DRUGTegafur

S-1 60mg/m2

RADIATIONradiotherapy

PTV 50Gy/2Gy


Locations(1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, China

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NCT06988956


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