e16222 Background: The management of advanced biliary tract cancers (BTC) remains a significant clinical challenge. Although the combination of immune checkpoint inhibitors (ICIs) with gemcitabine and cisplatin has established a new first-line standard of care, the clinical benefits are still limited. Surufatinib, a novel oral TKI, shows preclinical anti-tumor immune potential, but robust clinical and real-world evidence for its combination with ICIs/chemotherapy in BTC is lacking. regarding the efficacy and safety of surufatinib in combination with ICIs and chemotherapy for BTC is currently lacking. Methods: This single-center retrospective real-world study (ChiCTR 2500100586) enrolled patients (pts) with BTC who received surufatinib combined with ICIs and chemotherapy. Patients were required to have at least one measurable lesion per RECIST 1.1 criteria. The primary endpoints were objective response rate (ORR) and progression-free survival (PFS), Secondary endpoints included disease control rate (DCR), and overall survival (OS). Results: As of the latest data cut-off on June 1, 2026, a subset of the planned sample size had been enrolled. （N=12）The combination regimen showed promising anti-tumor activity, with a confirmed ORR of 41% (5/12), consisting of 0 complete responses (CR) and 5 partial responses (PR).The DCR was 66% (8/12)，The preliminary median PFS was estimated to be 7.3 months .The safety profile of the regimen was generally consistent with the known profiles of the individual agents, with no new or unexpected safety signals identified. The most common grade ≥3 treatment-related adverse events (TRAEs) included hepatic impairment (8%); neutropenia, thrombocytopenia, hypertension, and proteinuria (all 0%). Most adverse events were manageable with dose modifications and supportive care. Conclusions: In this real-world study of first-line treatment for advanced BTC, surufatinib combined with ICIs plus gemcitabine-platinum chemotherapy demonstrated encouraging preliminary efficacy and manageable safety. Through synergistic effects (anti-angiogenesis + immunomodulation + cytotoxicity), this triple therapy is expected to break through the current efficacy bottleneck of conventional chemotherapy for advanced BTC. Larger sample size and longer follow-up are needed to validate these findings. Clinical trial information: ChiCTR2500100586. Best tumor response and treatment- related advers evevts. Best Tumor Response evaluated Treatment-related adverse events Study Endpoint N=12 Adverse events N=12 ORR，N(%)【95% CI】 5（41%）(15.24~72.38) AEs，N(%) 11（91%） 95% CI (61.51~99.79) DCR，N(%)【95% CI 】 8（66%) (34.99~89.43) TEAEs N(%) 11（91%）95% CI (61.51~99.79) CR，N(%)【95% CI】 0（0%）(0.00~26.55) SAEs，N(%) 0（0%）95% CI ( 0.00~26.55) Surgery，N(%)【95% CI 】 1（8%）(0.21~38.43) irAEs，N(%) 1（8%）95% CI (34.99~89.43) mPFS 7.3（months） Grade≥3，N(%) 1（8%）95% CI (34.99~89.43)
Fan et al. (Thu,) studied this question.