Actively Recruiting
Clinical Study on the First-line Treatment of Advanced Colorectal Cancer With Simultaneous Infusion of Levozolinate for Injection and 5-FU
Led by Chinese PLA General Hospital · Updated on 2026-02-06
583
Participants Needed
1
Research Sites
237 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Phase II study of simultaneous infusion of levozolinate for injection and 5-FU as first-line treatment for advanced colorectal cancer
CONDITIONS
Official Title
Clinical Study on the First-line Treatment of Advanced Colorectal Cancer With Simultaneous Infusion of Levozolinate for Injection and 5-FU
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects voluntarily joined the study and signed informed consent
- Age between 18 and 75 years old
- ECOG performance status score of 0 to 2
- Histologically or cytologically confirmed unresectable or metastatic colorectal cancer with known primary tumor location and RAS and BRAF status
- No prior treatment for unresectable or metastatic lesions
- At least one measurable lesion according to RECIST 1.1 criteria
- No serious abnormalities in blood cell counts and normal heart, lung, liver, and kidney functions before treatment including:
- Hemoglobin 70 g/L
- White blood cell count 3.010^9/L; Neutrophil count 1.510^9/L
- Platelet count 10010^9/L
- Liver enzymes (AST or ALT) 2.5 times upper limit of normal
- Serum creatinine and total bilirubin 1.5 times upper limit of normal
- Expected survival longer than three months
You will not qualify if you...
- Allergic to the study drug or its ingredients
- Has contraindications to chemotherapy
- Diagnosed with MSI-H or dMMR colorectal cancer
- Pregnant or breastfeeding
- History of other malignant tumors
- Has systemic diseases or mental disorders making chemotherapy unsuitable
- Deemed unsuitable for the study by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chinese PLA General Hospital, Beijing
Beijing, China
Actively Recruiting
Research Team
G
Guanghai Dai
CONTACT
M
miaomiao Gou
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here