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NCT Number: NCT07309289

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

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

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Key information

Conditions

Metastatic Colorectal Cancer (CRC) Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Shanghai Zhongshan Hospital

Shanghai, China

Location status: Recruiting

Location contact

CONTACT

+86-21-64041990

About this study

This is a multicentre, open-label, randomised study to explore the safety and efficacy of NALIRIFOX plus targeted therapy versus FOLFOX plus targeted therapy as first-line treatment for metastatic colorectal cancer.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Underweight (body mass index [BMI]<18.5 kg/m^2
  • Known or suspected central nervous system metastasis
  • Received irinotecan before enrollment
  • Had undergone surgery and other oncologic treatments within the first 4 weeks of enrollment
  • Previous treatment-related toxicity didn't return to NCI-CTCAE v5.0 class I or below.
  • The use of CYP3A, CYP2C8, and UGT1A1 inhibitors or inducers couldn't be discontinued or were not discontinued within 2 weeks prior to enrollment
  • Serious gastrointestinal disorders
  • Interstitial lung disease
  • Tendency of arterial embolism and massive bleeding within 6 months before enrollment (except surgical bleeding)
  • Patients with fluid accumulation that couldn't reach a stable state and small amount of pleural effusion or ascites on imaging without clinical symptoms could be enrolled
  • Intestinal obstruction, or a risk of intestinal obstruction in the short term
  • Gastrointestinal perforation, intraperitoneal abscess, and fistula
  • Any serious or uncontrolled systemic disease, including uncontrolled high blood pressure, heart disease, active bleeding, active viral infection, etc
  • Have had other malignancies within the past 5 years or currently, except cured cervical carcinoma in situ, uterine carcinoma in situ, and non-melanoma skin cancer
  • Patients of childbearing age who refuse to take contraceptives, women who are pregnant or breastfeeding
  • The researchers didn't consider it appropriate to participate in this study

Treatment and study plan

NALIRIFOX plus targeted therapy

Drug

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.

FOLFOX plus targeted therapy

Drug

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.

Primary outcomes

  1. 18 month PFS rate

    Time frame: Eighteen months after the randomization of research participants

    To investigate the preliminary antitumor efficacy of study.

Secondary outcomes

  1. Objective response rate

    Time frame: From date of randomization until the date of first documented progression、termination of treatment, or date of death from any cause, whichever came first, assessed up to 12 months

    To investigate the preliminary antitumor efficacy of study.

  2. Disease control rate

    Time frame: From date of randomization until the date of first documented progression、termination of treatment, or date of death from any cause, whichever came first, assessed up to 12 months

    To investigate the preliminary antitumor efficacy of study.

  3. Progression free survival

    Time frame: From date of randomization until the date of first documented progression、termination of treatment, or date of death from any cause, whichever came first, assessed up to 12months

    To investigate the preliminary antitumor efficacy of study.

  4. R0 resection

    Time frame: From date of randomization until the date of surgical resection, assessed up to 12 months

    To assess surgical conversion rates in patients who could be surgically resected.

  5. Overall survival

    Time frame: From date of randomization until the date of death from any cause, assessed up to 30 months

    To investigate the preliminary antitumor efficacy of study.

Study contacts

Contact information is provided by the study sponsor or research team.

Tianshu Liu, Doctor

CONTACT

[email protected]

+86-21-64041990

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Dec 30, 2025
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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