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

NCT07309289 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2025-12-30

No results posted yet for this study

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.

Conditions

  • Metastatic Colorectal Cancer (CRC)

Interventions

DRUG

NALIRIFOX 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.

DRUG

FOLFOX 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.

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2029-03-01
Completion
2029-09-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07309289 on ClinicalTrials.gov