Fruquintinib With or Without HAI-FOLFOX for Refractory Colorectal Cancer

Recruiting now · Phase 2/Phase 3

Conditions studied: Colorectal Cancer

In brief

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.

Key facts

Study ID

NCT06441565

Run by

Sun Yat-sen University

People needed

84

Starts

2024-05-24

Expected to finish

2029-12-30

Last updated by the study team

2025-07-30

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged between 18 and 75 years.
• Histologically confirmed colorectal adenocarcinoma.
• Radiologically or pathologically confirmed liver metastasis.
• At least one measurable lesion (per RECIST v1.1 criteria).
• No extrahepatic metastasis confirmed by CT, MRI, or PET/CT (if necessary). Patients with minimal extrahepatic metastatic burden (defined as the presence of lung metastasis and/or lymph node metastasis with lung lesion diameter not exceeding 1 cm, and lymph node metastasis with the longest diameter less than 2 cm) can be included.
• 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)), with previous oxaliplatin-induced neurotoxicity < 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: 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).
• ECOG performance status 0-1.
• Expected survival >3 months.
• Signed written informed consent.
• Willing and able to undergo follow-up until death or study completion/termination.

You may not qualify if…

• 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 such as cerebrovascular accident (within 6 months prior to enrollment), myocardial infarction (within 6 months prior to enrollment), uncontrolled hypertension despite appropriate medical therapy, unstable angina, congestive heart failure (NYHA Class 2-4), or arrhythmias requiring medication.
• History or physical examination indicative of central nervous system diseases (e.g., primary brain tumors, uncontrolled seizures, any history of brain metastasis or stroke).
• Other malignancies within the past 5 years (except for radically treated basal cell carcinoma of the skin and/or carcinoma in situ of the cervix).
• Received any investigational drug treatment within 28 days prior to the study.
• Residual toxicity from previous chemotherapy (excluding alopecia), such as peripheral neuropathy ≥ Grade 2 (NCI CTCAE v5.0), if considering an oxaliplatin-containing regimen.
• Allergy to any of the study drugs.
• Pregnant or breastfeeding women.
• Women of childbearing potential not using or refusing to use effective non-hormonal contraception (intrauterine device, barrier method combined with spermicide, or sterilization) or men with reproductive potential.
• Inability or unwillingness to comply with the study protocol.
• Presence of any other diseases, functional impairment due to metastatic lesions, or findings on physical examination suggesting a contraindication to the use of the study drugs or putting the participant at high risk for treatment-related complications.

Where it is running

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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