drugset / Trial / NCT05435014
T-ACE Oil by TAE/TACE in Patients With Hepatocellular Carcinoma
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The phase I/II, double-blind, randomized study will investigate the efficacy and safety of TACE/TAE treatment with T-ACE Oil in patients with unresectable hepatocellular carcinoma.
Timeline
- Start
- 2022-09-13
- Primary completion
- 2026-06-30
- Completion
- 2026-06-30
Publications
- Background Miyayama S, Yamashiro M, Okuda M, Yoshie Y, Sugimori N, Igarashi S, Nakashima Y, Notsumata K, Toya D, Tanaka N, Mitsui T, Matsui O. Chemoembolization for the treatment of large hepatocellular carcinoma. J Vasc Interv Radiol. 2010 Aug;21(8):1226-34. doi: 10.1016/j.jvir.2010.04.015. Epub 2010 Jul 3.
- Background Lencioni R, Llovet JM. Modified RECIST (mRECIST) assessment for hepatocellular carcinoma. Semin Liver Dis. 2010 Feb;30(1):52-60. doi: 10.1055/s-0030-1247132. Epub 2010 Feb 19.
- Background Lencioni R, de Baere T, Soulen MC, Rilling WS, Geschwind JF. Lipiodol transarterial chemoembolization for hepatocellular carcinoma: A systematic review of efficacy and safety data. Hepatology. 2016 Jul;64(1):106-16. doi: 10.1002/hep.28453. Epub 2016 Mar 7.
- Background Wang Z, Lin M, Lesage D, Chen R, Chapiro J, Gu T, Tacher V, Duran R, Geschwind JF. Three-dimensional evaluation of lipiodol retention in HCC after chemoembolization: a quantitative comparison between CBCT and MDCT. Acad Radiol. 2014 Mar;21(3):393-9. doi: 10.1016/j.acra.2013.11.006.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | T-ACE Oil | Unknown | — | Other |
| Comparator | lipiodol | Unknown | — | Other |