RecruitingPhase 3NCT07309289

NALIRIFOX Plus Targeted Therapy Versus FOLFOX Plus Targeted Therapy as First-line Treatment for Metastatic Colorectal Cancer

NALIRIFOX Plus Targeted Therapy Versus FOLFOX Plus Targeted Therapy as First-line Treatment for Metastatic Colorectal Cancer: a Multicentre, Open-label, Randomised Trial


Sponsor

Shanghai Zhongshan Hospital

Enrollment

144 participants

Start Date

Jul 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

To explore the safety and efficacy of NALIRIFOX plus targeted therapy versus FOLFOX plus targeted therapy as first-line treatment for metastatic colorectal cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two chemotherapy regimens — NALIRIFOX (a newer combination including liposomal irinotecan) and FOLFOX (a standard combination) — each paired with targeted therapy, as first-line treatment for people with metastatic (spread) colorectal cancer. **You may be eligible if...** - You are 18 or older - You have a confirmed diagnosis of inoperable metastatic colorectal cancer (adenocarcinoma) - You have not yet received any systemic treatment for your metastatic disease - If you had prior neoadjuvant/adjuvant therapy, your disease must have progressed at least 12 months after that treatment ended - You have at least one measurable tumor on imaging (per RECIST 1.1 criteria) - Your physical performance status is ECOG 0 or 1 (fully active or mildly restricted) **You may NOT be eligible if...** - You have already received systemic therapy for your metastatic disease - Your performance status is too poor (ECOG 2 or above) - Your bone marrow, organ function, or other lab values do not meet requirements 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

DRUGNALIRIFOX plus targeted therapy

Drug: Irinotecan Liposome Irinotecan liposome injection will be administered by an intravenous infusion at the dose of 50 mg/m\^2, d1, 14 days per cycle. Drug: Oxaliplatin 75 mg/m\^2, intravenously infusion, d1, 14 days per cycle. Drug: 5-FU 2400mg/m\^2, intravenous infusion, d1-2, 14 days per cycle. Drug: LV/l-LV 400mg/m\^2 or 200mg/m\^2 , intravenous infusion, d1, 14 days per cycle. Drug: Bevacizumab 5mg/kg, intravenous infusion, d1, 14 days per cycle. Drug: Cetuximab 500mg/m\^2, intravenous infusion, d1, 14 days per cycle.

DRUGFOLFOX plus targeted therapy

Drug: Oxaliplatin 85 mg/m\^2, intravenously infusion, d1, 14 days per cycle. Drug: 5-FU 2400mg/m\^2, intravenous infusion, d1-2, 14 days per cycle. Drug: LV/l-LV 400mg/m\^2 or 200mg/m\^2 , intravenous infusion, d1, 14 days per cycle. Drug: Bevacizumab 5mg/kg, intravenous infusion, d1, 14 days per cycle. Drug: Cetuximab 500mg/m\^2, intravenous infusion, d1, 14 days per cycle.


Locations(1)

Shanghai Zhongshan Hospital

Shanghai, China

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NCT07309289


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