Actively Recruiting
NALIRIFOX Plus Targeted Therapy Versus FOLFOX Plus Targeted Therapy as First-line Treatment for Metastatic Colorectal Cancer
Led by Shanghai Zhongshan Hospital · Updated on 2025-12-30
144
Participants Needed
1
Research Sites
217 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To explore the safety and efficacy of NALIRIFOX plus targeted therapy versus FOLFOX plus targeted therapy as first-line treatment for metastatic colorectal cancer.
CONDITIONS
Official 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 old or older
- Histopathologically confirmed inoperable metastatic colorectal adenocarcinoma
- Unresectable metastatic disease with no prior systemic antitumor therapy
- At least 12 months since last neoadjuvant or adjuvant therapy if previously treated
- At least one measurable lesion per RECIST v1.1 criteria
- ECOG performance status of 0 or 1
- Normal bone marrow and organ function
- Voluntarily agree to participate and provide informed consent
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
- Previous irinotecan treatment
- Surgery or other oncologic treatments within 4 weeks before enrollment
- Untreated previous treatment-related toxicity worse than NCI-CTCAE v5.0 grade 1
- Use of CYP3A, CYP2C8, or UGT1A1 inhibitors or inducers not discontinued at least 2 weeks before enrollment
- Serious gastrointestinal disorders
- Interstitial lung disease
- Recent arterial embolism or massive bleeding within 6 months
- Unstable fluid accumulation or small asymptomatic pleural effusion/ascites allowed
- Intestinal obstruction or risk of obstruction
- Gastrointestinal perforation, abscess, or fistula
- Serious uncontrolled systemic diseases
- Other malignancies within past 5 years except certain cured cancers
- Women pregnant, breastfeeding, or refusing contraception
- Investigator judges participation inappropriate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Zhongshan Hospital
Shanghai, China
Actively Recruiting
Research Team
T
Tianshu Liu, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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