Study protocol: targeted delivery of interleukin-12 in combination with hepatic artery infusion pump therapy for patients with adrenocortical carcinoma liver metastases

作者：Lindsay R. Friedman, Emily C. Smith, A. Leila Sarvestani, Alyssa V. Eade, Jason Ho, Tracey Pu, Carolina Larrain, Cathleen E. Hannah, Tamika Magee, Kathleen M. Smith, Audra Satterwhite, Sophia Xiao, Justine F. Burke, Surajit Sinha, Priyanka P. Desai, Kirsten Remmert, Michael J. Cavnar, James L. Gulley, Jeffrey Schlom, Jaydira del Rivero, Jonathan M. Hernandez · 发表于：BMC Cancer · 年份：2026 · DOI：10.1186/s12885-026-16425-0 · 研究领域：Hepatocellular Carcinoma Treatment and Prognosis、Adrenal and Paraganglionic Tumors、Cardiac tumors and thrombi

BACKGROUND: Adrenocortical carcinoma (ACC) is a rare, aggressive malignancy often detected at an advanced stage with limited effective treatment options beyond first-line chemotherapy. The liver is a common site of metastasis, and patients frequently present with substantial hepatic disease burden that precludes complete resection. Locoregional therapies, including hepatic artery infusion pump (HAIP) delivery of floxuridine, have not been thoroughly evaluated for treatment of ACC liver metastasis, likely due to its rare incidence and highly aggressive nature. PDS01ADC (previously referred to as NHS-IL12) is a novel antibody-drug conjugate designed to deliver the immunomodulatory cytokine interleukin-12 to areas of tumor necrosis and modulate the tumor microenvironment to support immune surveillance and cytotoxic tumor responses. Combination of PDS01ADC with HAIP therapy (HAIP-delivered floxuridine plus systemic chemotherapy) was recently found to be feasible for clinical evaluation by an interim analysis in patients with colorectal liver metastases. Patients who received PDS01ADC with HAIP therapy had extended overall survival compared to patients who received HAIP therapy alone in a nonrandomized prior sequential study. We discuss herein the rationale and initiation of a new clinical trial arm to evaluate HAIP therapy with PDS01ADC for patients with ACC liver metastasis who have failed standard of care therapy. METHODS: Patients with unresectable ACC liver metastasis and eit...