Abstract Background The management of metastatic colorectal cancer (mCRC) in late-line settings remains a significant clinical challenge. The SUNLIGHT trial, which investigated the combination of trifluridine-tipiracil (FTD-TPI) and bevacizumab, reported a median progression-free survival (PFS) of 5 months and an objective response rate (ORR) of 6.3%. This phase II study was conducted to evaluate the potential of combining anlotinib with FTD-TPI as a third-line treatment strategy in patients with refractory mCRC. Methods In this open-label, single-arm phase II study, mCRC patients who had experienced disease progression following at least two prior standard treatment regimens were enrolled. Participants received a combination of anlotinib (12 mg, PO, QD, days 1-14, q3w) and FTD-TPI (35 mg/m2, PO, BID, days 1-5, q2w). The primary endpoint was the ORR. Secondary endpoints included disease control rate (DCR), PFS, overall survival (OS) and safety. Results As of May 30, 2025, twenty-one patients with mCRC were enrolled in this study. The median age was 62 years, with 71.4% male participants. Among the 20 evaluable patients, 2 achieved a partial response (PR), 16 had stable disease (SD) at the first evaluation. The ORR was 10.0% (2/20), and the DCR reached 90.0% (18/20). Based on Kaplan-Meier estimates, the median PFS was 5.6 months. The most common grade ≥3 treatment emergent adverse event (TEAEs) were neutropenia (25%) and thrombocytopenia (5%). Conclusion The combination of anlotinib and FTD-TPI demonstrated promising efficacy and a manageable safety profile, supporting its potential as a favorable late-line treatment option for patients with refractory mCRC. ClinicalTrials.gov Identifier ChiCTR2400079535
Liu et al. (Thu,) studied this question.