Fruquintinib Plus TAS-102 With or Without SBRT as Third- Or Later-Line Therapy for Metastatic Colorectal Cancer: Preliminary Results From a Prospective Phase II Trial.

, bid, days 1-5; 15-19) orally every 4 weeks until disease progression or intolerable toxicity. The primary endpoint was progression-free survival (PFS, per RECIST 1.1); secondary endpoints included overall survival (OS), objective response rate (ORR), disease control rate (DCR), and adverse events (AEs, graded using CTCAE v5.0). By January 20, 2025, 40 patients were enrolled (FTS group, 11; FT group, 29), with a median follow-up of 8.48 months. In 20 (50%) patients, the number of metastatic organs was ≥ 3. However, the number of metastatic lesions was > 5 in 32 (80%) patients. For the 36 eligible patients, the ORR and DCR were 19.4% and 88.9%, respectively. The median PFS was 8.58 months; however, the median OS has not been attained. The most common treatment-related AE was decreased white blood cell count (92.5%); grade 3-4 AEs included decreased lymphocyte count (12.5%). No treatment-related death occurred. Fruquintinib combined with TAS-102, with or without SBRT, showed promising preliminary efficacy and acceptable safety as third- or later-line treatment of mCRC.