OncoMatch/Clinical Trials/NCT06018714
Efficacy of Modified Fruquintinib in Colorectal Cancer Liver Metastases: A Phase II Study
Is NCT06018714 recruiting? Yes, currently enrolling (May 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
Cancer type
Colorectal Cancer
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
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.
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