Phase II study of simultaneous infusion of levozolinate for injection and 5-FU as first-line treatment for advanced colorectal cancer
To observe and evaluate the efficacy and safety of simultaneous infusion of levofolinate for injection and 5-FU in the first-line treatment of advanced colorectal cancer
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
583
mFOLFOX6: Oxaliplatin 85mg/m², intravenous infusion for 2 hours, day 1; 5-FU 400mg/m² injection, d1; Levofolic acid for injection at 200mg/m² and 5-FU at 2400mg/m² were mixed and infused simultaneously for 46 to 48 hours. Repeat every two weeks until disease progression or intolerable toxicity occurs. FOLFIRI: Irinotecan 180mg/m², intravenous infusion for 30 to 90 minutes on day 1; 5-FU 400mg/m² injection d1; Levofolic acid for injection at 200mg/m² and 5-FU at 2400mg/m² were mixed and infused simultaneously for 46 to 48 hours. Repeat every two weeks until disease progression or intolerable toxicity occurs.
Chinese PLA General Hospital, Beijing
Beijing, China
RECRUITINGPFS
Time frame: up to 3 years
ORR
Time frame: up to 3 years
DCR
Time frame: up to 3 years
DoR
Time frame: up to 3 years
OS
Time frame: up to 3 years
Adverse Event
Time frame: Thirty days after the last treatment
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