AI Article Synopsis

  • Hepatocellular carcinoma (HCC) is a major cancer that is often diagnosed in its intermediate stage, with transarterial chemoembolisation (TACE) being the standard treatment, particularly using the drug idarubicin (IDA).
  • This clinical trial aims to improve treatment effectiveness by exploring the interplay of local pharmacology, tumor targeting, and HCC biology, utilizing two different doses of IDA in patients with intermediate-stage HCC.
  • The study involves detailed analyses like blood and tissue biopsies, PET/MRI scans, and multiple omics approaches to better understand the tumor characteristics and drug response, while ensuring ethical standards and participant consent throughout the research process.

Article Abstract

Introduction: Hepatocellular carcinoma (HCC) is a common cause of cancer-related death, often detected in the intermediate stage. The standard of care for intermediate-stage HCC is transarterial chemoembolisation (TACE), where idarubicin (IDA) is a promising drug. Despite the fact that TACE has been used for several decades, treatment success is unpredictable. This clinical trial has been designed believing that further improvement might be achieved by increasing the understanding of interactions between local pharmacology, tumour targeting, HCC pathophysiology, metabolomics and molecular mechanisms of drug resistance.

Methods And Analysis: The study population of this single-centre clinical trial consists of adults with intermediate-stage HCC. Each tumour site will receive TACE with two different IDA doses, 10 and 15 mg, on separate occasions. Before and after each patient's first TACE blood samples, tissue and liquid biopsies, and positron emission tomography (PET)/MRI will be performed. Blood samples will be used for pharmacokinetics (PK) and liver function evaluation. Tissue biopsies will be used for histopathology analyses, and culturing of primary organoids of tumour and non-tumour tissue to measure cell viability, drug response, multiomics and gene expression. Multiomics analyses will also be performed on liquid biopsies. PET/MRI will be used to evaluate tumour viability and liver metabolism. The two doses of IDA will be compared regarding PK, antitumour effects and safety. Imaging, molecular biology and multiomics data will be used to identify HCC phenotypes and their relation to drug uptake and metabolism, treatment response and survival.

Ethics And Dissemination: Participants give informed consent. Personal data are deidentified. A patient will be withdrawn from the study if considered medically necessary, or if it is the wish of the patient. The study has been approved by the Swedish Ethical Review Authority (Dnr. 2021-01928) and by the Medical Product Agency, Uppsala, Sweden.

Trial Registration Number: EudraCT number: 2021-001257-31.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9644353PMC
http://dx.doi.org/10.1136/bmjopen-2022-065839DOI Listing

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