RecruitingPhase 2NCT06718205

Nimotuzumab Combined With Sintilimab and Chemotherapy for Advanced Esophageal Squamous Cell Carcinoma

Open-label, Single-arm, Multicenter Phase II Study of Nimotuzumab Injection Combined With Sintilimab and Chemotherapy as First-line Treatment for Advanced Esophageal Squamous Cell Carcinoma


Sponsor

The First Affiliated Hospital of Zhengzhou University

Enrollment

112 participants

Start Date

Mar 8, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a prospective, single-arm, multicenter study. The patients were given chemotherapy with nimotuzumab and sindilimab. To analyze the efficacy and safety of nimotuzumab combined with sindilizumab and chemotherapy in first-line treatment of advanced or recurrent or metastatic esophageal cancer.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three treatments — nimotuzumab (a targeted therapy), sintilimab (an immunotherapy), and standard chemotherapy — for patients with advanced squamous cell cancer of the esophagus (the tube connecting your throat to your stomach) that cannot be surgically removed. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with advanced, unresectable, or metastatic esophageal squamous cell carcinoma confirmed by biopsy - You have not had prior systemic treatment, OR your cancer returned more than 6 months after finishing a prior treatment course - You are in reasonably good physical condition (ECOG score 0-1) - Your life expectancy is at least 3 months - Your blood counts and organ function (liver, kidney, heart) are within acceptable ranges **You may NOT be eligible if...** - You have previously used anti-EGFR, anti-PD-1, anti-PD-L1, or anti-CTLA-4 immunotherapy drugs - Your tumor is causing a nearly complete blockage of the esophagus or has formed a fistula (abnormal opening) - You had major surgery within the past 28 days - You have chronic diarrhea, bowel obstruction, or difficulty swallowing 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

Combined chemotherapy phase Nimotuzumab 400mg,I.V.,D1,QW Maintenance treatment period:Until unbearable or PD Nimotuzumab 400mg,I.V.,D1,Q3W

DRUGSintilimab

Sintilimab 200mg,I.V.,D1,Q3W,Until unbearable or PD

DRUGPaclitaxel-albumin

Paclitaxel-albumin 200 mg/m2,I.V.,D1,Q3W,4-6 Cycle

DRUGCisplatin

Cisplatin:75 mg/m2,I.V.,D1,Q3W,4-6 Cycle


Locations(1)

Feng Wang

Zhengzhou, Henan, China

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NCT06718205


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