Efficacy and Safety of Fruquintinib Plus TAS‐102 in Patients With Previously Treated Metastatic Colorectal Cancer: Results From a Single‐Arm, Multi‐Center, Phase II Study

ABSTRACT The clinical efficacy of currently available third‐ and later‐line treatment regimens for patients with metastatic colorectal cancer (mCRC) remains suboptimal. This study was designed to investigate fruquintinib plus TAS‐102 regimen in this patient population. This study was a prospective, multi‐center, single‐arm phase II trial. A total of 50 patients with mCRC who had experienced treatment failure to at least two standard therapies were enrolled. The primary endpoint was progression‐free survival (PFS) and secondary endpoints included overall survival (OS), objective response rate (ORR), disease control rate (DCR), and safety. Survival outcomes were estimated using the Kaplan–Meier method. With a median follow‐up duration of 25.1 months, the median PFS was 6.07 months (95% CI: 4.07–7.87) and the median OS was 14.10 months (95% CI: 9.84–23.28). The ORR was 10.0% (95% CI: 3.3–21.8), with a DCR of 66.0% (95% CI: 51.2–78.8). All the patients experienced treatment‐related adverse events (TRAEs), with 68.0% reporting grade ≥ 3 TRAEs. No serious adverse events (AEs), deaths, or new safety concerns were reported. In conclusion, fruquintinib combined with TAS‐102 showed preliminary anti‐tumor activity with a manageable safety profile in patients with refractory mCRC, which highlights its potential as a viable later‐line therapeutic option. Trial Registration : NCT05004831