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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Zhongshan Hospital

About this trial

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

Qualifiers

≥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

Disqualifiers

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

Underweight (body mass index [BMI]<18.5 kg/m²

Known or suspected central nervous system metastasis

Trial design

Treatments tested in this trial

  • NALIRIFOX plus targeted therapy
  • FOLFOX plus targeted therapy

Treatment groups

144 Participants
are divided into 2 treatment groups

Sponsors and collaborators