Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07432568
Brief Summary:
This is a prospective, single-center, single-arm clinical study. It aims to evaluate the efficacy and safety of a new combination therapy as a first-line treatment for patients with advanced intrahepatic cholangiocarcinoma (ICC) who cannot be treated with surgery. The combined therapy includes hepatic arterial infusion chemotherapy (HAIC) with Liposomal Irinotecan, 5-Fluorouracil, and Leucovorin, along with the oral targeted drug Lenvatinib and an intravenous PD-1 inhibitor (an immunotherapy). A total of 30 participants will be enrolled. The main goal of the study is to measure the Objective Response Rate (ORR), which is the percentage of patients whose cancer shrinks or disappears after treatment.
Detailed Description:
This study investigates a novel therapeutic strategy for unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma (ICC). Despite being the second most common primary liver malignancy, advanced ICC has a poor prognosis with limited effective first-line treatment options. The rationale for this combination regimen is based on the potential synergy between localized and systemic therapies. Hepatic arterial infusion chemotherapy delivers high concentrations of chemotherapy directly to the liver tumors, potentially improving local control while reducing systemic toxicity. The combination of Lenvatinib, a multi-targeted tyrosine kinase inhibitor, and a PD-1 inhibitor is designed to simultaneously inhibit tumor angiogenesis and enhance anti-tumor immunity. This study will explore whether combining these modalities (HAIC + targeted therapy + immunotherapy) can yield superior efficacy compared to historical data of standard chemotherapy. The liposomal formulation of irinotecan is utilized for its improved pharmacokinetic profile and targeted delivery, which may enhance efficacy and tolerability. Key assessments include tumor evaluation based on RECIST 1.1 criteria and safety monitoring per NCI CTCAE v5.0.
Study:
NCT07432568
Study Brief:
Protocol Section:
NCT07432568