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

December 28, 2025 updated by: Tianshu Liu, Shanghai Zhongshan Hospital

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

144

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Shanghai Zhongshan Hospital
        • Contact:
          • Phone Number: +86-21-64041990

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NALIRIFOX plus targeted therapy
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.
Active Comparator: FOLFOX plus targeted therapy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
18 month PFS rate
Time Frame: Eighteen months after the randomization of research participants
To investigate the preliminary antitumor efficacy of study.
Eighteen months after the randomization of research participants

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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.
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
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.
From date of randomization until the date of surgical resection, assessed up to 12 months
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.
From date of randomization until the date of death from any cause, assessed up to 30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2025

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

September 1, 2029

Study Registration Dates

First Submitted

December 15, 2025

First Submitted That Met QC Criteria

December 28, 2025

First Posted (Actual)

December 30, 2025

Study Record Updates

Last Update Posted (Actual)

December 30, 2025

Last Update Submitted That Met QC Criteria

December 28, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSPC-DEY-CRC-K10

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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