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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endostar | Drug |
| ||
| Oxaliplatin |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | the end of the 3rd cycle |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liming Zhu, MD | Contact | 0571-88122222 |
| Name | Affiliation | Role |
|---|---|---|
| Liming Zhu, MD | Zhejiang Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | China |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C522911 | endostar protein |
| D000077150 | Oxaliplatin |
| D002955 | Leucovorin |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
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|
| Folinic acid | Drug |
|
| 5-FU | Drug |
|
| Incidence of Adverse Events |
| up to 1 month after the last cycle |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D005492 |
| Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |