Actively Recruiting
NALIRIFOX Plus Targeted Therapy Versus FOLFOX Plus Targeted Therapy as First-line Treatment for Metastatic Colorectal Cancer: a Multicentre, Open-label, Randomised Trial
Led by Shanghai Zhongshan Hospital · Updated on 2025-12-30
144
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of NALIRIFOX combined with targeted therapy compared to FOLFOX combined with targeted therapy as the first treatment for patients with metastatic colorectal cancer. This is a Phase 3, multicenter, open-label, randomized trial designed to compare these two treatment approaches in people with this advanced cancer. Participants receive either NALIRIFOX plus targeted therapy or FOLFOX plus targeted therapy. NALIRIFOX treatment includes intravenous infusions of irinotecan liposome, oxaliplatin, 5-FU, leucovorin, bevacizumab, and cetuximab given every 14 days in cycles. The comparator group receives FOLFOX plus targeted therapy including oxaliplatin, 5-FU, leucovorin, bevacizumab, and cetuximab, also administered intravenously every 14 days. Both treatments are given as first-line therapy for metastatic colorectal cancer. Participants will be monitored regularly to assess treatment response and safety. Assessments include measuring progression-free survival rates at 18 months, tumor response and control rates up to 12 months, surgical resection outcomes, and overall survival up to 30 months. Study visits involve physical exams, lab tests, and imaging to evaluate disease status and side effects. The study is expected to follow participants for over four years to collect comprehensive data on treatment effects and patient outcomes.
CONDITIONS
Brief Title
NALIRIFOX Plus Targeted Therapy Versus FOLFOX Plus Targeted Therapy as First-line Treatment for Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older
- Histopathologically confirmed inoperable metastatic colorectal adenocarcinoma
- No prior systemic antitumor therapy for unresectable metastatic disease
- At least 12 months since last neoadjuvant or adjuvant therapy if previously given
- At least one measurable lesion per RECIST v1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Normal bone marrow and organ function
- Signed informed consent voluntarily to participate
You will not qualify if you...
- Known MSI-H or dMMR suitable for immune checkpoint inhibitors
- Allergy to investigational drugs or excipients
- Underweight with BMI less than 18.5 kg/m²
- Known or suspected central nervous system metastasis
- Prior irinotecan treatment
- Surgery or oncologic treatments within 4 weeks before enrollment
- Unresolved treatment-related toxicity above grade 1 per NCI-CTCAE v5.0
- Use of CYP3A, CYP2C8, or UGT1A1 inhibitors or inducers not discontinued within 2 weeks
- Serious gastrointestinal disorders
- Interstitial lung disease
- Recent arterial embolism or major bleeding within 6 months
- Unstable fluid accumulation requiring treatment
- Intestinal obstruction or risk of obstruction
- Gastrointestinal perforation, abscess, or fistula
- Serious uncontrolled systemic diseases including high blood pressure, heart disease, active bleeding, or infection
- Other malignancies within 5 years except certain cured cancers
- Women pregnant, breastfeeding, or refusing contraceptives if of childbearing age
- Considered inappropriate for participation by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 14-day cycles until disease progression or discontinuation
Participants receive either NALIRIFOX plus targeted therapy or FOLFOX plus targeted therapy as first-line treatment for metastatic colorectal cancer.
Visits every 14 days for drug infusions
Duration - Up to 30 months after randomization
Participants are monitored for outcomes including progression-free survival and overall survival after treatment ends.
Periodic visits as scheduled for assessments
Trial Site Locations
Total: 1 location
1
Shanghai Zhongshan Hospital
Shanghai, China
Actively Recruiting
Research Team
T
Tianshu Liu, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here