Recombinant Human Endostatin in Combination With XELOX Therapy in Patient With Advanced Colorectal Cancer.

Study Overview
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Brief Summary
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To study safety and efficacy of intravenous pump of recombinant human endostatin combined with XELOX-treated and also investigate the potential value of CECs level for the prediction of PD and outcomes in patients with advanced colorectal cancer.

Official Title
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Effect of Intravenous Pump of Recombinant Human Endostatin Combined With XELOX Chemotherapy, and a Potential Prognostic Biomarkers in Patient With Advanced Colorectal Cancer

Conditions
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Quality of Life

Intervention / Treatment
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* Drug: oxaliplatin + capecitabine (XELOX chemotherapy)
* Drug: rebombniant human endostatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clear pathology diagnosis of stage for the Ⅳ period of advanced colorectal cancer. There are at least 1 imaging examinations according to the standard of RECIST（the longest diameter is at least 10mm with spiral CT and 20mm with ordinary CT）. Male or female , age 18～75 Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. The patients had to have a life expectancy of at least 3 months. A white blood count (WBC) greater than 3000/mm3, platelets greater than 100 000/mm3, and normal coagulation values. Aspartate aminotransferase (AST) and adenosine triphosphate (ALT) values were to be less than 2.5 times the upper limit of normal;a bilirubin level of less than 25 lmol/l；a creatinine value less than 130 lmol/l. Informed consent was obtained from all patients. Exclusion Criteria: Patients having a brain tumor or brain metastases, a bleeding disorder, receiving anti-coagulant therapy. a history of myocardial infarction or angina pectoris in the last 6 months or uncontrolled congestive heart failure, having an active infection or receiving radio- or chemotherapy within 4 weeks before study. patients with uncontrolled serious medical or psychiatric illness or having any other condition that was likely to interfere with regular follow-up.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients were randomly assigned to receive either three treatment cycles of intravenous pump of recombinant human endostatin before chemotherapy.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: XELOX chemotherapy with recombinant human endotatin<br>Patients received a triweekly treatment cycle.Oxaliplatin(130mg/m2 over 2h)was intravenously administated for at least 2h on day 1. Capecitabine(1000mg/m2 twice daily)was oral administrated from the evening of day 1 to the morning of day 15.The dose of Recombinant human endostatin on day -5 was calculated according to the patients's body surface area, to provide a CIV 7 days' dose in physiological saline to 240mL volume. | Drug: oxaliplatin + capecitabine (XELOX chemotherapy)<br>* Oxaliplatin(130mg/m2 over 2h)was intravenously administated for at least 2h on day 1. Capecitabine(1000mg/m2 twice daily)was oral administrated from the evening of day 1 to the morning of day 15.<br>Drug: rebombniant human endostatin<br>* Endostar is a recombinat human endostatin with antiangiogenic properties that has been useful in treating a wide range of cancers and shows promise for use in combination treatment for advanced colorectal cancer. The dose of Recombinant human endostatin on day -5 was calculated according to the patients's body surface area, to provide a CIV 7 days' dose in physiological saline to 240mL volume.<br>|
| Active Comparator: XELOX chemotherapy without recombinant human endotatin<br>Patients received a triweekly treatment cycle.Oxaliplatin(130mg/m2 over 2h)was intravenously administated for at least 2h on day 1. Capecitabine(1000mg/m2 twice daily)was oral administrated from the evening of day 1 to the morning of day 15. | Drug: oxaliplatin + capecitabine (XELOX chemotherapy)<br>* Oxaliplatin(130mg/m2 over 2h)was intravenously administated for at least 2h on day 1. Capecitabine(1000mg/m2 twice daily)was oral administrated from the evening of day 1 to the morning of day 15.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival | Evaluate the effect of XELOX therapy with or without recombinant human endostatin on progression free survival | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| local control | To describe local control and out-of-field disease progression | 4 years | 
| Overall survival | comparison to maintenance XELOX chemotherapy alone. | 4 years |