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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China
RECRUITINGObjective 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
Time frame: 2 years
Progression-free survival (PFS)
The date from random to the first occurrence of disease progression or death from any cause, whichever comes first
Time frame: 2years
Disease control rate (DCR)
The proportion of patients whose BOR is CR, PR, and stable disease (SD) assessed
Time frame: 2years
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