Combination of Nimotuzumab,Capecitabine and Radiotherapy for Inoperable or Recurrent Gastric Cancer

Study Overview
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Brief Summary
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The prognosis of patients with inoperable locally advanced or residual/relapsed gastric cancer is rather poor. Concurrent capecitabine chemoradiotherapy is safe and recommended. Nimotuzumab, an anti-EGFR (epidermal growth factor receptor) monoclonal antibody, has shown its antitumor safety and efficiency in many phase I/II studies. Efficiency of combination of these treatment need to be further analyzed.

Detailed Description
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There is no standard treatment for patients with inoperable locally advanced or residual/relapsed gastric cancer. For the former ones, 5-fluorouracil(5-FU) based concurrent chemoradiotherapy is a recommended treatment regimen. Concurrent capecitabine chemoradiotherapy showed similar results. So far, more and more studies have shown that drugs targeting at EGFRs play an important role in antitumor treatment. Nimotuzumab, an anti-EGFR monoclonal antibody, has shown its safety and efficiency in many phase I/II studies. Because of poor survival of patients with inoperable locally advanced or residual/relapsed gastric cancer, the efficiency of nimotuzumab plus concurrent capecitabine chemoradiotherapy need to be further analyzed.

Official Title
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Phase II Study of Nimotuzumab and Concurrent Radiotherapy and Capecitabine for Inoperable Locally Advanced or Recurrent Gastric Cancer

Conditions
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Gastric Cancer, Concurrent Chemoradiotherapy

Intervention / Treatment
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* Drug: nimotuzumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-75 years old, male or female Gastric cancer with measurable lesions, and the diameter is at least 1 cm Karnofsky score: at least 70 Estimated survival: at least 6 months No prior target therapy or radiotherapy No severe hypertension, cardiac disease, or diabetes mellitus Normal blood routine and chemical tests Signed consent Exclusion Criteria: Other malignancies simultaneously except in situ cervix or non-melanoma skin cancer Extensive distant metastases Pregnancy or in lactation Allergic to 5-Fluorouracil

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<br>Combination of nimotuzumab and capecitabine concurrent chemoradiotherapy is received by patients. | Drug: nimotuzumab<br>* 200 milligram (mg) of nimotuzumab per week during radiation period<br>* Other names: Nimotuzumab injection, Tai Xin-sheng;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival | progression-free survival: the time between tumor regression to progression | 1 year progression-free survival | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall responses | the overall responses: complete response (CR)+ partial response(PR)+ stable disease (SD) rates based on World Health Organization(WHO) evaluation system | 1 month after treatment | 
| overall survival time | median overall survival time | 1 month after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric cancer, concurrent chemoradiotherapy, target therapy