Intera Oncology

Assessment of Hepatic Arterial Infusion of Floxuridine in Combination With Systemic Gemcitabine and Oxaliplatin in Patients With Unresectable Intrahepatic Cholangiocarcinoma A Phase 2 Clinical Trial

Andrea Cercek, Thomas Boerner, Benjamin R Tan, Joanne F Chou, Mithat Gönen, Taryn M Boucher, Haley F Hauser, Richard K G Do, Maeve A Lowery, James J Harding, Anna M Varghese, Diane Reidy-Lagunes, Leonard Saltz, Nikolaus Schultz, T Peter Kingham, Michael I D'Angelica, Ronald P DeMatteo, Jeffrey A Drebin, Peter J Allen, Vinod P Balachandran, Kian-Huat Lim, Francisco Sanchez-Vega, Neeta Vachharajani, Maria B Majella Doyle, Ryan C Fields, William G Hawkins, Steven M Strasberg, William C Chapman, Luis A Diaz Jr, Nancy E Kemeny, William R Jarnagin

JAMA Oncol. – Oct, 2019

In this single arm, prospective, Phase II clinical trial, unresectable patients with no distant metastases treated with HAI therapy along with systemic chemotherapy reached median overall survival of 25.0 months and the 1-year OS rate of 89.5%.

Twenty-two patients (58%) achieved a partial radiographic response, and 32 patients (84%) achieved disease control at 6 months. Four patients had sufficient response to undergo resection, and 1 patient had a complete pathologic response.
The median progression free survival was 11.8 months (1-sided 90% CI, 11.1) with a 6-month PFS rate of 84.1%(90% CI, 74.8%-infinity), thereby meeting the primary end point (6-month PFS rate, 80%).
Patients with resectable regional lymph nodes (18 [47%]) showed no difference in OS compared with patients with node-negative disease.
In a confirmatory phase I/II study of 10 patients at a separate hospital, 9 patients (90%) achieved disease control at 6 months.

Study limitations: there is the possibility of selection bias owing to small sample size.¹

¹Cercek A, Boerner T, Tan BR, et al : Assessment of Hepatic Arterial Infusion of Floxuridine in Combination With Systemic Gemcitabine and Oxaliplatin in Patients With Unresectable Intrahepatic Cholangiocarcinoma A Phase 2 Clinical Trial. JAMA Oncol. L2020;6(1):60-67