Phase II study of simultaneous infusion of levozolinate for injection and 5-FU as first-line treatment for advanced colorectal cancer
The subjects voluntarily joined this study and signed the informed consent form.
Age: 18 to 75 years old, gender not limited;
ECOG PS score: 0-2 points
Patients with unresectable or metastatic colorectal cancer confirmed by histology or cytology, where the primary tumor location and the status of RAS and BRAF are known;
Those who have been confirmed to be allergic to the test drug and/or its excipients;
Those with contraindications to chemotherapy;
Colorectal cancer patients with MSI-H or dMMR;
Pregnant or lactating women;
Parallel
mFOLFOX/FOLFIRI ( Standard Chemotherapy)
DrugmFOLFOX6: 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.
PFS
ORR
DCR
DoR
OS
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