Randomized Phase 3 LEAP-012 Study: Transarterial Chemoembolization With or Without Lenvatinib Plus Pembrolizumab for Intermediate-Stage Hepatocellular Carcinoma Not Amenable to Curative Treatment.
Randomized Phase 3 LEAP-012 Study: Transarterial Chemoembolization With or Without Lenvatinib Plus Pembrolizumab for Intermediate-Stage Hepatocellular Carcinoma Not Amenable to Curative Treatment.
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DOI：
10.1007/s00270-021-03031-9
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发表时间：
2022-04
影响因子：
2.9
通讯作者：
Kudo M
中科院分区：
文献类型：
--
作者：
Llovet JM;Vogel A;Madoff DC;Finn RS;Ogasawara S;Ren Z;Mody K;Li JJ;Siegel AB;Dubrovsky L;Kudo M
Transarterial chemoembolization (TACE) is the standard of care for patients with intermediate-stage hepatocellular carcinoma (HCC). Lenvatinib, a multikinase inhibitor, and pembrolizumab, a PD-1 inhibitor, have shown efficacy and tolerability in patients with HCC, and adding this combination to TACE may enhance clinical benefit. LEAP-012 is a prospective, double-blind randomized phase 3 study. Adults with confirmed HCC localized to the liver without portal vein thrombosis and not amenable to curative treatment, ≥ 1 measurable tumor per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1), Eastern Cooperative Oncology Group performance status 0 or 1, Child–Pugh class A and no previous systemic treatment for HCC are eligible. Patients will be randomly assigned to lenvatinib once daily plus pembrolizumab every 6 weeks plus TACE or placebos plus TACE. Dual primary endpoints are overall survival and progression-free survival per RECIST 1.1 by blinded independent central review (BICR). Secondary endpoints are progression-free survival, objective response rate, disease control rate, duration of response and time to progression per modified RECIST by BICR; objective response rate, disease control rate, duration of response and time to progression per RECIST 1.1 by BICR; and safety. The planned sample size, 950 patients, was calculated to permit accumulation of sufficient overall survival events in 5 years to achieve 90% power for the overall survival primary endpoint. LEAP-012 will evaluate the clinical benefit of adding lenvatinib plus pembrolizumab to TACE in patients with intermediate-stage HCC not amenable to curative treatment. ClinicalTrials.gov NCT04246177.
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影响因子：
3.8
作者：
Miura S;Mitsuhashi N;Shimizu H;Kimura F;Yoshidome H;Otsuka M;Kato A;Shida T;Okamura D;Miyazaki M
通讯作者：
Miyazaki M
影响因子：
9.6
作者：
Poon, RTP;Ho, JWY;Fan, ST
通讯作者：
Fan, ST
影响因子：
30.5
作者：
Latchman, Y;Wood, CR;Freeman, GJ
通讯作者：
Freeman, GJ
影响因子：
45.3
作者：
Finn, Richard S.;Ikeda, Masafumi;Llovet, Josep M.
通讯作者：
Llovet, Josep M.
影响因子：
13.5
作者：
Lo, CM;Ngan, H;Wong, J
通讯作者：
Wong, J