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Clinical Study on the First-line Treatment of Advanced Colorectal Cancer With Simultaneous Infusion of Levozolinate for Injection and 5-FU
Sponsor: Chinese PLA General Hospital
Summary
Phase II study of simultaneous infusion of levozolinate for injection and 5-FU as first-line treatment for advanced colorectal cancer
Official title: A Study to Evaluate the Efficacy and Safety of a First-line Treatment for Advanced Colorectal Cancer With Simultaneous Infusion of Levozolinate for Injection and 5-FU
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
583
Start Date
2025-05-15
Completion Date
2029-12
Last Updated
2026-02-06
Healthy Volunteers
No
Conditions
Interventions
mFOLFOX/FOLFIRI ( Standard Chemotherapy)
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.
Locations (1)
Chinese PLA General Hospital, Beijing
Beijing, China