OncoMatch/Clinical Trials/NCT06018714
Efficacy of Modified Fruquintinib in Colorectal Cancer Liver Metastases: A Phase II Study
Is NCT06018714 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Fruquintinib for colorectal cancer metastatic.
Treatment: Fruquintinib — The overall 5-year survival rate for patients with colorectal liver metastases (CRLM) is still less than 20%. Surgery-based local treatment can achieve no evidence of disease (NED) in CRLM patients, but over 60% of patients experience recurrence even after achieving NED. Even with adjuvant therapy for the 6-month perioperative period after achieving NED, the recurrence rate remains high. Fruquintinib is a selective anti-angiogenic inhibitor that may help reduce tumor recurrence and prolong the time to recurrence and metastasis. The Chinese Society of Clinical Oncology (CSCO) guidelines have recommended fruquintinib as a third-line therapy for colorectal cancer. This study aims to evaluate the effectiveness and safety of fruquintinib as a maintenance therapy for patients with advanced colorectal cancer (CRC) who have achieved no evidence of disease (NED) after completing adjuvant chemotherapy.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Colorectal Cancer
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Must have received: chemotherapy — first-line
Patients who have previously received first-line chemotherapy and have achieved disease control (PR+SD) according to RECIST 1.1
Must have received: adjuvant chemotherapy (CapOX, FOLFOX) — adjuvant
Completed adjuvant chemotherapy after achieving NED (e.g. 4-8 cycles of CapOX regimen, 6-12 cycles of FOLFOX regimen, or without receiving adjuvant chemotherapy recently) and evaluated as no disease progression. Last chemotherapy within 2 months from enrollment.
Must have received: local therapy (surgery, ablation, SBRT) — liver metastasis
Patients with liver metastasis of colorectal cancer who have undergone curative local treatment (surgery, ablation, SBRT) and achieved no evidence of disease (NED).
Lab requirements
Blood counts
WBC > 3 × 10^9 / L; PLT > 80 × 10^9 / L; Hb > 90 g/L
Kidney function
Serum creatinine ≤ 1.5 × ULN or creatinine clearance rate (CCr) ≥ 60 ml/min
Liver function
ALT and AST ≤ 2.5 × ULN; bilirubin ≤ 1.5 × ULN
Cardiac function
Left ventricular ejection fraction <50% on echocardiography, poorly controlled arrhythmias, active cardiac disease within 6 months prior to treatment, including myocardial infarction, severe/unstable angina pectoris
Hematology: WBC > 3 × 10^9 / L; PLT > 80 × 10^9 / L; Hb > 90 g/L; Liver function: ALT and AST ≤ 2.5 × ULN; bilirubin ≤ 1.5 × ULN; Renal function: Serum creatinine ≤ 1.5 × ULN or creatinine clearance rate (CCr) ≥ 60 ml/min; Active cardiac disease within 6 months prior to treatment, including myocardial infarction, severe/unstable angina pectoris. Left ventricular ejection fraction <50% on echocardiography, poorly controlled arrhythmias.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06018714 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received chemotherapy and adjuvant chemotherapy.
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