Nimotuzumab in Combination With Radiotherapy for Esophageal Cancer

Study Overview
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Brief Summary
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Nimotuzumab (hR3) is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical efficacy has been shown in adult with head and neck cancer. The phase II study assessed the efficacy and safety of the combination of Nimotuzumab administered concomitantly with radiotherapy in patients with esophageal cancer tumours.

Detailed Description
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Clinical efficacy has been shown in adult with head and neck cancer. The phase II study assessed the efficacy and safety of the combination of Nimotuzumab administered concomitantly with radiotherapy in patients with esophageal cancer tumours.

Official Title
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The Phase II of Nimotuzumab in Combination With Radiotherapy for Esophageal Cancer

Conditions
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Esophageal

Intervention / Treatment
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* Drug: Nimotuzumab
* Radiation: Radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pathologically or cytology diagnosed phase II-III esophageal carcinoma or IV thoracic segments carcinoma with the supraclavicular lymph nodes metastasis. with the measureable lesion of the newly diagnosed the esophageal carcinoma. age 18-75 years old ECOG≤2 Expect survival date ≥3 months without serious diseases of important organs signature in the inform consent. Exclusion Criteria: pregnant or breast-feeding women or using a prohibited contraceptive method. with psychiatric diseases. with serious diseases or uncontrolled infection. with history of other tumors. participation other clinical trials within 1 month prior to inclusion in the trial. not the first antitumor treatment .

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nimotuzumab group<br>Nimotuzumab+radiotherapy | Drug: Nimotuzumab<br>* the nimotuzumab treatment; 200mg/w,weekly,5-6 weeks.<br>Radiation: Radiotherapy<br>* the Radiotherapy treatment;95%PTV A dose of 50-60Gy will be administered in 25-30 fractions ( 2 Gy /fraction)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of AE(adverse event) or toxicity ( Both acute and chronic toxicity will be evaluated.) | assement of advers event after using medication based TAAE evaluation form | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete response |  | 3 months | 
| Partial response (PR) |  | 3 months | 
| Stable disease (SD) |  | 3 months | 
| Progressive disease (PD) |  | 3 months | 
| Median survival time (MST) |  | 2 years | 
| Overall survival (OS) |  | 1 year,2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nimotuzumab esophageal radiotherapy