GEMOX-HAIC Plus GEM-SYS in Combination With Lenvatinib and PD-1 Inhibitor for Large Unresectable ICC

This study aimed to preliminarily evaluate the clinical efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) of gemcitabine and oxaliplatin (GEMOX) plus systemic gemcitabine chemotherapy (GEM-SYS) combined with lenvatinib and programmed cell death protein-1 (PD-1) inhibitor in patients with large unresectable intrahepatic cholangiocarcinoma (uICC). Large uICC patients who underwent GEMOX-HAIC (Day 1) and GEM-SYS (Day 8) (3w/cycle) combined with lenvatinib and PD-1 inhibitor between November 2019 and December 2022 were enrolled. Clinical data were retrospectively collected to analyze local tumor response, progression-free survival (PFS), overall survival (OS), and adverse events (AEs). Tumor response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. AEs were evaluated by the common terminology criteria for adverse events (CTCAE) version 5.0. In this study, OS was the primary endpoint, and progression-free survival (PFS) was the secondary endpoint.

NCT Number	NCT06505486
Lead Sponsor	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Conditions	Intrahepatic Cholangiocarcinoma
Enrollment	21 participants
Start Date	2024-07-10
Primary Completion	2025-07-10 (estimated)
Study Completion	2025-07-10 (estimated)
Updated on ClinicalTrials.gov	2024-07-17