NCT05435014 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

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.
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.
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.
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.

Phase I/II Randomized, Double-Blind, First-in-Human Study of T-ACE Oil by Trans-Catheter Arterial Embolization or ChemoEmbolization (TAE/TACE) in Patients With Hepatocellular Carcinoma

Details for clinical trial NCT05435014

Clinical trial NCT05435014 - References