Study of Endostar With Cisplatin and Capecitabine as 1st Line Treatment in the Advanced Gastric Cancer

Study Overview
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Brief Summary
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The purpose of this study is to investigate whether endostar (recombinant human endostatin)with cisplatin and capecitabine (Xeloda) as 1st line treatment in the advanced gastric cancer is effective and safe.

Detailed Description
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Endostar, a recombinant human endostatin, has shown its antitumor ability in combination in NSCLC and breast cancer. But to gastric cancer, few clinical data has been reported. However, bevacizumab, an angiogenesis inhibitor was shown effective in combination with chemotherapy in advanced gastric cancer in some phase II study. So in this study, we want to explore whether endostar is also effective and safe in advanced gastric cancer. Response predictive factor is expected to be identified.

Official Title
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A Phase II Study of Endostar (Recombinant Human Endostatin ®) With Cisplatin and Capecitabine (Xeloda) as 1st Line Treatment in the Advanced Gastric Cancer

Conditions
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Advanced Gastric Cancer

Intervention / Treatment
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* Drug: endostar, cisplatin, capecitabine
* Drug: capecitabine
* Drug: cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Having signed informed consent Age 18 to 70 years old Histologically confirmed gastric adenocarcinoma Unresectable recurrent or metastatic disease Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months Previous chemotherapy with capecitabine or cisplatin, if applicable, more than 12 months. Measurable disease according to the RECIST criteria Karnofsky performance status ≥60 Life expectancy of ≥2 month No prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks ALT and AST<2.5 times ULN (≤5 times ULN in patients with liver metastases) Serum albumin level ≥3.0g/dL Serum AKP < 2.5 times ULN Serum creatinine <ULN, and CCr < 60ml/min Bilirubin level < 1.5 ULN WBC>3,000/mm3, absolute neutrophil count ≥2000/mm3, platelet>100,000/mm3, Hb>9g/dl Exclusion Criteria: Brain metastasis (known or suspected) Previous systemic therapy for metastatic gastric cancer Inability to take oral medication Previous therapy targeting at angiogenesis or vasculogenesis pathway or other targeted therapy Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry Contraindications of nuclear magnetic resonance image such as fitment of cardiac pacemaker , nerve stimulator, or aneurysm clip, and metallic foreign body in eye ball and so on. Allergic constitution or allergic history to protium biologic product or any investigating agents. Severe heart disease or such history as recorded congestive heart failure, uncontrolled cardiac arrhythmia, angina pectoris needing medication, cardiac valve disease, severe abnormal ECG findings, cardiac infarction , or retractable hypertension. Pregnancy or lactation period Any investigational agent within the past 28 days Other previous malignancy within 5 year, except non-melanoma skin cancer Previous adjuvant therapy with capecitabine+platinum, Pre-existing neuropathy>grade 1 Legal incapacity

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: endostar+chemotherapy<br> | Drug: endostar, cisplatin, capecitabine<br>* Product 1: endostar Dosing schedule: 15mg daily dose, d1-14 Mode of administration: intravenously<br>Drug: capecitabine<br>* Product 2: capecitabine Dosing schedule: 1000mg/m2 bid, days 1-14, every 3 weeks Mode of administration: orally<br>Drug: cisplatin<br>* Product 3: cisplatin Dosing schedule: 80mg/m2, day 1 of every 3 weeks Mode of administration: intravenously<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | 3 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor response rate |  | 1 year | 
| Disease control rate |  | 1 year | 
| Overall survival |  | 5 year | 
| adverse evens |  | 5 year | 
| The alteration of relative regional blood volume of the tumor |  | 3weeks |