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.

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.