Recruiting Phase 2

Clinical Study on the First-line Treatment of Advanced Colorectal Cancer With Simultaneous Infusion of Levozolinate for Injection and 5-FU

About this study

Phase II study of simultaneous infusion of levozolinate for injection and 5-FU as first-line treatment for advanced colorectal cancer

Minimum age: 18 years
Maximum age: 75 years
Study condition: 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;
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.

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.

1 site, 1 recruiting

Chinese PLA General Hospital, Beijing

Beijing, China

Recruiting

Potential match only. Final eligibility is determined by the study team.