OncoMatch/Clinical Trials/NCT06441565
Fruquintinib With or Without HAI-FOLFOX for Refractory Colorectal Cancer
Is NCT06441565 recruiting? Yes, currently enrolling (May 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
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)
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.
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