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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:

Article Synopsis
  • TACE is the standard treatment for patients with unresectable, non-metastatic hepatocellular carcinoma, and this study evaluates the effectiveness of adding lenvatinib and pembrolizumab to TACE compared to a placebo.
  • 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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Background: Historically, soil-transmitted helminth (STH) control and prevention strategies have relied on mass drug administration efforts targeting preschool and school-aged children. While these efforts have succeeded in reducing morbidity associated with STH infection, recent modeling efforts have suggested that expanding intervention to treatment of the entire community could achieve transmission interruption in some settings. Testing the feasibility of such an approach requires large-scale clinical trials, such as the DeWorm3 cluster randomized trial.

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Objectives: To investigate how studies determine the sample size when developing radiomics prediction models for binary outcomes, and whether the sample size meets the estimates obtained by using established criteria.

Methods: We identified radiomics studies that were published from 01 January 2023 to 31 December 2023 in seven leading peer-reviewed radiological journals. We reviewed the sample size justification methods, and actual sample size used.

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Importance: Recently, the US Food and Drug Administration gave premarketing approval to an algorithm based on its purported ability to identify individuals at genetic risk for opioid use disorder (OUD). However, the clinical utility of the candidate genetic variants included in the algorithm has not been independently demonstrated.

Objective: To assess the utility of 15 genetic variants from an algorithm intended to predict OUD risk.

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Cerasus is a subgenus of Prunus in the family Rosaceae that is popular owing to its ornamental, edible, and medicinal properties. Understanding the evolution of the Cerasus subgenus and identifying selective trait loci in edible cherries are crucial for the improvement of cherry cultivars to meet producer and consumer demands. In this study, we performed a de novo assembly of a chromosome-scale genome for the sweet cherry (Prunus avium L.

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