Clinical Study on the First-line Treatment of Advanced Colorectal Cancer With Simultaneous Infusion of Levozolinate for Injection and 5-FU
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
Chinese PLA General Hospital
583 participants
May 15, 2025
INTERVENTIONAL
Conditions
Summary
Phase II study of simultaneous infusion of levozolinate for injection and 5-FU as first-line treatment for advanced colorectal cancer
Eligibility
Inclusion Criteria12
- 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;
- No previous treatment for unresectable or metastatic lesions has been received;
- There is at least one measurable lesion in accordance with the RECIST 1.1 standard;
- In the pre-treatment examination indicators, there was no serious hematopoietic function abnormality, and the functions of the heart, lungs, liver and kidneys were basically normal.
- Hemoglobin (Hb) ≥70 g/L;
- White blood cell count (WBC) ≥3.0×109/L; Neutrophil count (NEUT) ≥1.5×109/L;
- Platelet count (PLT) ≥100×109/L;
- Liver function (aspartate aminotransferase AST or alanine aminotransferase ALT) level ≤2.5 times the upper limit of normal value (ULN); Renal function (serum creatinine sCr) level ≤1.5 times the upper limit of the normal value (ULN). Total bilirubin (TBIL) ≤1.5 times the upper limit of the normal value (ULN).
- The expected survival period is more than three months.
Exclusion Criteria7
- 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;
- There is a history of other malignant tumors in the past;
- Those with systemic internal diseases and mental disorders who are not suitable for chemotherapy;
- Patients who were determined by the researchers to be unsuitable for inclusion in this study.
Interventions
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)
View Full Details on ClinicalTrials.gov
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NCT07391618