Actively Recruiting
Fruquintinib With or Without HAI-FOLFOX for Refractory Colorectal Cancer
Led by Sun Yat-sen University · Updated on 2025-07-30
84
Participants Needed
1
Research Sites
292 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The objective of this clinical trial is to evaluate the efficacy and safety of combining fruquintinib with hepatic artery infusion (HAI)-FOLFOX in the treatment of refractory colorectal cancer with liver metastasis.
CONDITIONS
Official Title
Fruquintinib With or Without HAI-FOLFOX for Refractory Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 75 years
- Histologically confirmed colorectal adenocarcinoma
- Radiologically or pathologically confirmed liver metastasis
- At least one measurable lesion according to RECIST v1.1
- No extrahepatic metastasis, or minimal extrahepatic metastasis with lung lesions ≤1 cm and lymph nodes <2 cm
- Disease progression within 3 months or intolerance to standard fluoropyrimidine, irinotecan, oxaliplatin combined with targeted therapy
- Previous oxaliplatin-induced neurotoxicity less than Grade 2
- Normal hematologic function (platelets >90×10^9/L; white blood cells >3×10^9/L; neutrophils >1.5×10^9/L)
- Serum bilirubin ≤1.5 times the upper limit of normal (ULN), transaminases ≤5 times ULN, alkaline phosphatase ≤2.5 times ULN
- No ascites
- Coagulation function within 1.5 times ULN (PT, INR, APTT)
- Albumin ≥35 g/L
- Child-Pugh grade A liver function
- Serum creatinine less than ULN or creatinine clearance >50 ml/min
- ECOG performance status 0-1
- Expected survival longer than 3 months
- Signed written informed consent
- Willing and able to undergo follow-up until death or study completion/termination
You will not qualify if you...
- Severe arterial embolism
- Bleeding tendency or coagulation disorders
- Hypertensive crisis or hypertensive encephalopathy
- Severe uncontrolled systemic complications such as infection or diabetes
- Clinically significant cardiovascular diseases including stroke or myocardial infarction within 6 months, uncontrolled hypertension, unstable angina, congestive heart failure (NYHA Class 2-4), or arrhythmias requiring medication
- History or signs of central nervous system diseases such as brain tumors, uncontrolled seizures, brain metastasis, or stroke
- Other malignancies within the past 5 years except treated basal cell carcinoma or carcinoma in situ of the cervix
- Received investigational drug treatment within 28 days prior to study
- Residual toxicity from previous chemotherapy of Grade 2 or higher peripheral neuropathy
- Allergy to any study drugs
- Pregnant or breastfeeding women
- Women of childbearing potential not using effective non-hormonal contraception or men with reproductive potential
- Inability or unwillingness to comply with study protocol
- Any other diseases or findings indicating contraindication to study drugs or high risk for treatment complications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
Y
Yuhong Li, PhD
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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