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Recruiting Phase 3 NCT07309289

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

Trial Parameters

Condition Metastatic Colorectal Cancer (CRC)
Sponsor Shanghai Zhongshan Hospital
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 144
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-07-01
Completion 2029-03-01
Interventions
NALIRIFOX plus targeted therapyFOLFOX plus targeted therapy

Brief 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 Criteria

Inclusion Criteria: * ≥18 years old * Histopathologically confirmed patient with an inoperable metastatic colorectal adenocarcinoma * The unresectable stage of metastatic disease has not received any systemic antitumor therapy * For subjects previously receiving neoadjuvant or adjuvant therapy, the date of first discovery of disease progression must be at least 12 months removed from the date of last administration of neoadjuvant or adjuvant therapy * The presence of at least 1 measurable lesion that can be evaluated according to the RECIST v1.1 criteria * ECOG 0\~1 * Normal bone marrow and organ function * Understand the situation of this study, patients and/or legal representatives voluntarily agree to participate in this study and sign informed consent form Exclusion Criteria: * Patients with known MSI-H or dMMR who were evaluated by investigators as suitable for treatment with immune checkpoint inhibitors. * Patients allergic to the investigational drug and its excipients * Underwe

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