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Transarterial chemoembolisation combined with lenvatinib plus pembrolizumab versus dual placebo for unresectable, non-metastatic hepatocellular carcinoma (LEAP-012): a multicentre, randomised, double-blind, phase 3 study.

Lancet

January 2025

Mount Sinai Liver Cancer Program, Division of Liver Diseases, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA; Liver Cancer Translational Research Group, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Hospital Clínic, Universitat de Barcelona, Barcelona, Spain; Institució Catalana de Recerca i Estudis Avançats, Barcelona, Spain. Electronic address:

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  • The multicenter, randomised, double-blind phase 3 study (LEAP-012) involved participants from 137 sites across 33 countries who were randomly assigned to receive either TACE with the new drugs or TACE with a placebo.
  • The primary endpoints were progression-free survival and overall survival, and the results reported are from the first interim analysis, which serves as the final analysis for progression-free survival.
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