Evaluating the Safety and Efficacy of SB Injection in Patients With Advanced or Metastatic Colorectal Cancer

Study Overview
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Brief Summary
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The purpose of this study is to determine efficacy of SB injection in Colorectal Cancer.

Detailed Description
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All eligible patients will receive SB injection therapy for 6 cycles (14 21 days for each cycle). Efficacy will be evaluated every 3 cycles.

Official Title
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Phase Ⅱ,Open Label Clinical Trial to Investigate Safety and Efficacy of SB Injection in Patients With Advanced and Metastatic Colorectal Cancer

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: SB injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of 18years or over Patients who had failed more than 1 cycle of standard therapy with advanced or metastatic stage and with measurable lesions Life expectancy >/= 5 months Not available to any of resectable surgery or radiotherapy Patients with adequate organ(e.g. heart, kidney, liver)and bone marrow function, as defined by Absolute neutrophil count >/= 1.0 x 10^9/L, Platelet count >/= 75 x 10^9/L Total bilirubin < 2.0 mg/dL Aspartate Aminotransferase and/or Aspartate Aminotransferase < 5 x Upper Limit Normal creatinine < 2 x Upper Limit Normal ECOG status 0 to 2 Female volunteers admitted to the study must be using a reliable means of contraception and must have a negative blood or urine pregnancy test at least 7days ago Patients or their legal representatives who have signed the informed consent form. Exclusion Criteria: Have inflammatory bowel diseases Have severe diarrhea or ileus Previous total colectomy Have ileostomy Known brain or spinal cord metastases Patients who have received chemotherapy within the previous 4 weeks Patients who have received radiotherapy related tp colorectal cancer within 4weeks Patients who have participated in other clinical study within the previous 4weeks Pregnancy or lactation period Human Immunodeficiency Virus antibody (+) Have active infection or serious concomitant systemic disorder incompatible with the study Clinically hypertension or diabetes mellitus not well controlled with medication Clinically significant cardiac disease(congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias) or myocardial infarction Presence or history of malignancy other than colorectal cancer within 5years Have severe Neurologic or psychological disorder Patients who have history of allergy with this investigational drug(SB injection) Obvious cognitive or physical impairment that would prevent participation

Ages Eligible for Study
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Minimum Age: 18 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

| Intervention/Treatment |
| --- |
|Drug: SB injection|Infusion SBinjection of 21.87ml/m^2, IV route, 24times for 4 months|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluating Tumor Response Rate |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores on the Visual Analog Scale |  | 4 months | 
| evaluate patient's performance by measuring Eastern Cooperative Oncology Group scale |  | 4 months | 
| Determine duration of response rate by measuring time to progression |  | 4 months |