Endostar Combined With mFOLFOX6 for First-line Treatment of Metastatic Colorectal Cancer

Study Overview
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Brief Summary
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This study is to assess the efficacy and safety of Endostar combined with mFOLFOX6 in untreated metastatic colorectal cancer patients, and to find the markers that may predict the efficacy.

Official Title
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Study of Endostar Combined With mFOLFOX6 for First-line Treatment of Metastatic Colorectal Cancer and Efficacy Prediction

Conditions
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Metastatic Colorectal Cancer

Intervention / Treatment
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* Drug: Endostar
* Drug: Oxaliplatin
* Drug: Folinic acid
* Drug: 5-FU


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically confirmed metastatic colorectal cancer (adenocarcinoma) At least one measurable lesion (RECIST criteria) Life expectancy ≥ 3 months ECOG performance status 0-2 Adequate hematologic function: ANC ≥ 1.5×109 /L，Hb ≥ 90 g/L，PLT ≥ 100×109 /L Adequate renal function: Cr ≤ 1.25×ULN or Creatinine clearance ≥ 60 ml/min Adequate hepatic function: BIL ≤ 1.5×ULN, ALT/AST ≤ 2.5×ULN, Alkaline phosphatase ≤ 5×ULN Patients have not previously received palliative chemotherapy, immunological/ biological treatment No adjuvant chemotherapy in last six months Target lesion has not received local radiotherapy Written informed consent Exclusion Criteria: Diagnosis of colorectal neuroendocrine tumor, undifferentiated carcinoma, adenosquamous carcinoma, squamous cell carcinoma Evidence of serious or uncontrolled infection Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension) Pregnant or lactating women Women of childbearing potential refused to practice acceptable methods of birth control to prevent pregnancy Allergic to any of the study drug Intestinal obstruction, intestinal perforation, or stroke within 3 months Participation in other clinical studies

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: Treatment<br>Endostar d1-d7 15mg/d Oxaliplatin 85 mg/m2 d6 Folinic acid 400 mg/m2 d6 5-FU 400 mg/m2 d6, and then 5-FU 2,400 mg/m2 INTRAVENOUS over 46 h | Drug: Endostar<br> <br> Drug: Oxaliplatin<br> <br> Drug: Folinic acid<br> <br> Drug: 5-FU<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) |  | the end of the 3rd cycle | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood perfusion in tumor tissue |  | baseline, the end of the 3rd cycle | 
| Ratio of blood perfusion in tumor tissue to blood perfusion in surrounding normal tissue |  | baseline, the end of the 3rd cycle | 
| Incidence of Adverse Events |  | up to 1 month after the last cycle |