ABSTRACT Background Microsatellite stable/proficient mismatch repair (MSS/pMMR) colorectal cancer liver metastases (CRCLM) have limited treatment options after failure of second‐line systemic therapies. Hepatic artery infusion chemotherapy (HAIC) combined with targeted therapy and immunotherapy may offer improved outcomes. Methods This retrospective single‐center study compared the efficacy and safety of HAIC (oxaliplatin, 5‐fluorouracil, leucovorin) combined with regorafenib and sintilimab (HAIC‐R‐S) versus regorafenib monotherapy in MSS/pMMR CRCLM patients refractory to ≥ 2 lines of systemic therapy. Propensity score matching was used to balance baseline characteristics, resulting in 45 matched pairs ( n = 90). Survival outcomes, tumor response, and adverse events (AEs) were analyzed. Results The HAIC‐R‐S group showed significantly improved median progression‐free survival (PFS) (6.5 vs. 3.4 months; p < 0.001) and overall survival (OS) (14.1 vs. 8.1 months; p < 0.001) compared to regorafenib alone. Objective response rate (ORR) (37.8% vs. 2.2%; p < 0.001) and disease control rate (71.1% vs. 42.2%; p = 0.006) were also superior. Grade ≥ 3 AEs were more frequent in the combination group (26.7% vs. 13.3%), primarily hematologic toxicities. Conclusion In this retrospective, hypothesis‐generating study, HAIC (oxaliplatin, 5‐fluorouracil, leucovorin) combined with regorafenib and sintilimab showed improved PFS, OS, and ORRs compared with regorafenib monotherapy in refractory MSS/pMMR CRCLM, albeit with increased hematologic toxicity. These findings require validation in prospective, multicenter randomized trials before clinical implementation.
You et al. (Mon,) studied this question.
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