RecruitingPhase 2NCT07391618

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


Sponsor

Chinese PLA General Hospital

Enrollment

583 participants

Start Date

May 15, 2025

Study Type

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a first-line chemotherapy regimen for people with advanced colorectal cancer that has spread or cannot be surgically removed. It is testing the combination of a newer drug called levolinate (levozolinate) given at the same time as 5-FU, to see if this improves outcomes compared to standard treatment. **You may be eligible if...** - You are 18 to 75 years old - You have unresectable or metastatic colorectal cancer confirmed by biopsy - You have not yet received chemotherapy for your metastatic cancer - The genetic profile of your tumor (RAS and BRAF status) and primary tumor location are known - You have at least one measurable tumor and your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - You have already received treatment for metastatic colorectal cancer - You have serious heart, lung, liver, or kidney problems - You have active serious infections or uncontrolled other medical conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGmFOLFOX/FOLFIRI ( Standard Chemotherapy)

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)

Chinese PLA General Hospital, Beijing

Beijing, China

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NCT07391618


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