Actively Recruiting
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
Led by Chinese PLA General Hospital · Updated on 2026-02-06
583
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a first-line treatment using simultaneous infusion of levofolinate for injection and 5-FU for patients with advanced colorectal cancer. This Phase II study focuses on patients who have not previously received treatment for unresectable or metastatic colorectal cancer, with known tumor characteristics such as RAS and BRAF mutation status and tumor location. The goal is to observe how well this combination works and its safety profile in this patient group. The study involves two experimental treatment groups based on tumor genetics and location. Patients with wild-type RAS and BRAF and left-sided tumors receive either the mFOLFOX6 or FOLFIRI chemotherapy regimens combined with simultaneous infusion of levofolinic acid and 5-FU, with cetuximab added at the researchers' discretion. Patients with right-sided tumors or mutant RAS or BRAF receive the same chemotherapy regimens with the option to add bevacizumab. Treatments are repeated every two weeks until disease progression or unacceptable side effects occur. Participants will undergo various assessments including tumor measurements according to RECIST 1.1 criteria, blood tests to monitor organ function, and tracking of adverse events. The primary outcome is progression-free survival over up to three years, with secondary outcomes including response rates, disease control, duration of response, overall survival, and safety monitoring for 30 days after treatment ends. The total participation period may extend up to several years to observe these outcomes and ensure participant safety throughout the study.
CONDITIONS
Brief 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...
- Voluntarily agree to participate and sign informed consent.
- Age between 18 and 75 years, any gender.
- ECOG performance status score of 0 to 2.
- Diagnosed with unresectable or metastatic colorectal cancer confirmed by histology or cytology.
- Known primary tumor location and RAS and BRAF mutation status.
- No prior treatment for unresectable or metastatic lesions.
- At least one measurable lesion according to RECIST 1.1.
- Adequate blood counts and normal heart, lung, liver, and kidney function.
- Expected survival longer than three months.
You will not qualify if you...
- Known allergy to the study drug or its components.
- Contraindications to chemotherapy.
- Colorectal cancer with MSI-H or dMMR.
- Pregnant or breastfeeding women.
- History of other malignant tumors.
- Presence of systemic diseases or mental disorders that prevent chemotherapy.
- Deemed unsuitable for the study by researchers.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Repeated 14-day cycles until disease progression or discontinuation
Participants receive first-line treatment with simultaneous infusion of levofolinate for injection and 5-FU as part of chemotherapy regimens mFOLFOX6 or FOLFIRI. Treatment cycles repeat every two weeks until disease progression or intolerable toxicity occurs.
Visits every two weeks for infusion and monitoring
Duration - Up to 3 years
After completing treatment, participants are monitored for safety and long-term outcomes including adverse events and survival.
Periodic follow-up visits for up to 3 years after treatment
Trial Site Locations
Total: 1 location
1
Chinese PLA General Hospital, Beijing
Beijing, China
Actively Recruiting
Research Team
G
Guanghai Dai
M
miaomiao Gou
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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