A Phase 3 Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) with Pembrolizumab (MK-3475) in Combination with Transarterial Chemoembolization (TACE) Versus TACE in Participants with Incurable/Non-metastatic Hepatocellular Carcinoma (LEAP-012)
Protokollnummer: 012-03 (E7080-G000-318)
EudraCT nummer: 2019-002345-37
Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Hovedutprøver: Olav Dajani
Deltagende sentra: Ullevål.
Hepatocellulært karsinom; kreft i lever (CMS).
TACE – TransArteriell Chemo Embolisation. Prosedyren er nøye beskrevet i e-håndbok:
Virkestoff | Grunndose | Adm.måte | Oppløsningsvæske | Beh.dager |
Δ Doksorubicin Embozene Tandem | 150 mg | Intraarteriell injeksjon | 5 ml sterilt vann | 1 |
Kurintervall: Se studieprotokoll.