34A Single-Center Preliminary Experience with Systemic Chemo-Immunotherapy in Combination with Hepatic Arterial Infusion Floxuridine in Patients with Liver-Confined Intrahepatic Cholangiocarcinoma
Adel Kardosh, Ranish K Patel, Spencer Smith, Kathryn L Fowler, Shaun M Goodyear, Clay Kills First, Guillaume J Pegna, Emerson Y Chen, Charles D Lopez, Flavio G Rocha, Byung Park, Robert Eil, Skye C MayoAbstract
Background
The standard of care for unresectable cholangiocarcinoma (CCA) is gemcitabine/cisplatin and immune checkpoint inhibition (ICI) with durvalumab (GCD) or pembrolizumab (GCP). For patients (pts) with liver-confined intrahepatic CCA (iCCA), use of hepatic arterial infusion with floxuridine (HAI) has gained traction as trials report improved disease control and longer overall survival (OS). However, there is no safety data for combining systemic GCD/GCP and HAI.
Methods
A single-institution, prospective database collated outcomes for pts with liver-confined, unresectable iCCA between 2023-2025 that were treated with GCD/GCP followed by addition of HAI (floxuridine starting: 0.054 mg/kg/day). Data collected included timing and number of GCD/GCP cycles before/after HAI, adverse events (AEs, including immune-related AEs [irAEs]), maximal tumor response, disease control rate (DCR) at 6-months, and overall survival (OS).
Results
1Opts started HAI after completing a median of 7 cycles (range 3-15) of GCD(n=B) or GCP(n = 2). After HAI pump placement, median hospital stay was 4.5 days (range 4-7) and start of first HAI cycle was a median of 15.5 days (range 11-42). Following maximal systemic treatment, median tumor size increased 5.52% (IQR -14.1 to 21.3), but after adding HAI to GCD/GCP, median size of the dominant tumor decreased by 18.5, 20.5, and 22.6% after 2, 4, and 6 months, respectively (Table). At 6-months, DCR was 60% (6/10) and dominant tumor size decreased by a median of 23 mm (range 21-49). One pt converted to resectable disease and remains disease-free after 15 months. Grade 3 AEs and irAEs were 10%. No biliary stenting was required for pts with biliary sclerosis. The 12 and 24-month OS was 100%.
Conclusion
The addition of HAI to GCD/GCP appears safe, and a significant reduction in tumor size supports a potential for superior hepatic disease control compared to GCD/GCP alone. Additional clinical trials are warranted.