2025
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
Kudo M, Ren Z, Guo Y, Han G, Lin H, Zheng J, Ogasawara S, Kim J, Zhao H, Li C, Madoff D, Ghobrial R, Kawaoka T, Gerolami R, Ikeda M, Kumada H, El-Khoueiry A, Vogel A, Peng X, Mody K, Dutcus C, Dubrovsky L, Siegel A, Finn R, Llovet J, investigators L. 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. The Lancet 2025, 405: 203-215. PMID: 39798578, DOI: 10.1016/s0140-6736(24)02575-3.Peer-Reviewed Original ResearchConceptsEastern Cooperative Oncology GroupNon-metastatic hepatocellular carcinomaProgression-free survivalTreatment-related adverse eventsPembrolizumab groupPhase 3 studyTransarterial chemoembolisationPlacebo groupHepatocellular carcinomaIntention-to-treatOverall survivalDouble-blindPerformance statusAdverse eventsFollow-upEastern Cooperative Oncology Group performance statusChild-Pugh class A diseaseMedian progression-free survivalSolid Tumors version 1.1Blinded independent central reviewA-fetoprotein levelAlbumin-bilirubin gradeResponse Evaluation CriteriaAs-treated populationMedian follow-up
2022
Randomized Phase 3 LEAP-012 Study: Transarterial Chemoembolization With or Without Lenvatinib Plus Pembrolizumab for Intermediate-Stage Hepatocellular Carcinoma Not Amenable to Curative Treatment
Llovet JM, Vogel A, Madoff DC, Finn RS, Ogasawara S, Ren Z, Mody K, Li JJ, Siegel AB, Dubrovsky L, Kudo M. Randomized Phase 3 LEAP-012 Study: Transarterial Chemoembolization With or Without Lenvatinib Plus Pembrolizumab for Intermediate-Stage Hepatocellular Carcinoma Not Amenable to Curative Treatment. CardioVascular And Interventional Radiology 2022, 45: 405-412. PMID: 35119481, PMCID: PMC8940827, DOI: 10.1007/s00270-021-03031-9.Peer-Reviewed Original ResearchConceptsBlinded independent central reviewIntermediate-stage hepatocellular carcinomaDisease control rateObjective response rateProgression-free survivalDuration of responseHepatocellular carcinomaCurative treatmentRECIST 1.1Primary endpointClinical benefitControl rateEastern Cooperative Oncology Group performance status 0Response rateChild-Pugh class ARandomized phase 3 studyDual primary endpointsOverall survival eventsPerformance status 0Previous systemic treatmentPD-1 inhibitorsPortal vein thrombosisPhase 3 studyResponse Evaluation CriteriaSolid Tumors 1.1LEAP-012 trial in progress: Transarterial chemoembolization (TACE) with or without lenvatinib plus pembrolizumab for intermediate-stage hepatocellular carcinoma (HCC)
El-Khoueiry A, Llovet J, Vogel A, Madoff D, Finn R, Ogasawara S, Ren Z, Mody K, Li J, Siegel A, Dubrovsky L, Kudo M. LEAP-012 trial in progress: Transarterial chemoembolization (TACE) with or without lenvatinib plus pembrolizumab for intermediate-stage hepatocellular carcinoma (HCC). Journal Of Clinical Oncology 2022, 40: tps494-tps494. DOI: 10.1200/jco.2022.40.4_suppl.tps494.Peer-Reviewed Original ResearchBlinded independent central reviewIntermediate-stage hepatocellular carcinomaDisease control rateObjective response rateProgression-free survivalDuration of responseTransarterial chemoembolizationRECIST v1.1Hepatocellular carcinomaEnd pointCurative treatmentEastern Cooperative Oncology Group performance statusDual primary end pointsExploratory end pointsPrevious systemic treatmentPD-1 inhibitorsPortal vein thrombosisPrimary end pointSecond-line therapySecondary end pointsPhase 3 studyHealth-related qualityIntermediate hepatocellular carcinomaAdvanced hepatocellular carcinomaLimited treatment options
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