OncoMatch/Clinical Trials/NCT06441565
Fruquintinib With or Without HAI-FOLFOX for Refractory Colorectal Cancer
Is NCT06441565 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2/3 trial studies multiple treatments including Fruquintinib and Fluorouracil for colorectal cancer.
Treatment: Fruquintinib · Fluorouracil · Oxaliplatin — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Chemotherapy
Cancer type
Colorectal Cancer
Biomarker criteria
Required: KRAS wild-type
cetuximab (RAS/BRAF wild-type)
Required: NRAS wild-type
cetuximab (RAS/BRAF wild-type)
Required: BRAF wild-type
cetuximab (RAS/BRAF wild-type)
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: fluoropyrimidine
Disease progression within 3 months or intolerance to standard treatment with fluoropyrimidine, irinotecan, oxaliplatin combined with targeted therapy (including bevacizumab and cetuximab (RAS/BRAF wild-type))
Must have received: irinotecan
Disease progression within 3 months or intolerance to standard treatment with fluoropyrimidine, irinotecan, oxaliplatin combined with targeted therapy (including bevacizumab and cetuximab (RAS/BRAF wild-type))
Must have received: oxaliplatin
Disease progression within 3 months or intolerance to standard treatment with fluoropyrimidine, irinotecan, oxaliplatin combined with targeted therapy (including bevacizumab and cetuximab (RAS/BRAF wild-type))
Must have received: VEGF inhibitor (bevacizumab)
Disease progression within 3 months or intolerance to standard treatment with fluoropyrimidine, irinotecan, oxaliplatin combined with targeted therapy (including bevacizumab and cetuximab (RAS/BRAF wild-type))
Must have received: EGFR-targeted therapy (cetuximab)
Disease progression within 3 months or intolerance to standard treatment with fluoropyrimidine, irinotecan, oxaliplatin combined with targeted therapy (including bevacizumab and cetuximab (RAS/BRAF wild-type))
Lab requirements
Blood counts
platelets >90×10^9/L; white blood cells >3×10^9/L; neutrophils >1.5×10^9/L; albumin ≥35 g/L; PT/INR/APTT ≤1.5x ULN
Kidney function
Serum creatinine less than ULN, or calculated creatinine clearance >50 ml/min (Cockcroft-Gault)
Liver function
Serum bilirubin ≤1.5x ULN, transaminases ≤5x ULN, alkaline phosphatase ≤2.5x ULN, no ascites, Child-Pugh grade A liver function
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: prothrombin time (PT) ≤1.5 ULN; international normalized ratio (INR) ≤1.5 ULN; activated partial thromboplastin time (APTT) ≤1.5 ULN, albumin ≥35 g/L. Child-Pugh grade A liver function. Serum creatinine less than ULN, or calculated creatinine clearance >50 ml/min (using Cockcroft-Gault formula).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06441565 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received fluoropyrimidine and irinotecan.
Does this trial require KRAS?
Yes, KRAS wild-type is a required biomarker for enrollment.
Does this trial require NRAS?
Yes, NRAS wild-type is a required biomarker for enrollment.
Does this trial require BRAF?
Yes, BRAF wild-type is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages