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To observe and evaluate the efficacy and safety of FOLFOX/FOLFIRI± target-directed regimen containing Levofolinic Acid (Zuoyu ®) in first-line treatment of unresectable or metastatic colorectal cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FOLFOX/FOLFIRI | Experimental | q2w, after 8 cycles of medication or patient intolerance or disease progression; |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FOLFOX/FOLFIRI | Drug | mFOLFOX6 :oxaliplatin 85mg/m² IV infusion 2h d1, 5-FU 400mg/m² push d1, Then 5-FU 1200mg/(m2▪d)×2d+Levofolinic Acid 200mg/m² continuous mixed infusion for 46-48h (total 5-FU 2400mg/m²); FOLFIRI :Irinotecan 180mg/m ² static pulse infusion 30min~90min d1, 5-FU 400mg/m² push d1, Then 5-FU 1200mg/(m2▪d)×2d+ Levofolinic Acid 200mg/m² continuous mixed infusion for 46-48h (total 5-FU 2400mg/m²); The combination of cetuximab/bevacizumab and other targeted agents depends on the patient. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | The proportion of patients whose best overall response (BOR) is complete response (CR) or partial response (PR) assessed by iRECIST v1.1 | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | The date from random to the first occurrence of disease progression or death from any cause, whichever comes first | 2years |
| Disease control rate (DCR) | The proportion of patients whose BOR is CR, PR, and stable disease (SD) assessed |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jingdong Zhang | Contact | +86-13804027878 | zhangjingdong@cancerhosp-ln-cmu.com | |
| Qian Dong | Contact | dongqian08@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liaoning Cancer Hospital & Institute | Recruiting | Shenyang | Liaoning | 110042 | 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 |
|---|---|
| C410216 | Folfox protocol |
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|
| 2years |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |