Randomized controlled study of TACE therapy for HCC comparing epi-ADM and CDDP

Authors
Category Primary study
JournalUMIN Clinical Trials Registry
Year 2006
INTERVENTION: Make Cisplatin‐Lipiodol suspension and infuse it into hepatic artery, followed by Gelpart infusion. Dissolve Epirubicin in a contrast medium and then mix with Lipiodol, and infuse it into hepatic artery, followed by Gelpart infusion. CONDITION: Hepatocellular carcinoma PRIMARY OUTCOME: Anti‐tumor activity (Response rate = CR+PR). ; Response will be evaluated mainly according to the EASL (European Association for the Study of the Liver) guideline. .; Secondarily it will be evaluated according to the Criteria for the Evaluation of Direct Effects of Hepatocellular Carcinoma (2004) and RESIST. SECONDARY OUTCOME: Survival rate and local‐relapse‐free survival/QOL survey INCLUSION CRITERIA: 1)A patient who has non‐resectable hepatocellular carcinoma confirmed histologically and clinically, and is not suitable for the local treatment. 2)A patient who has the localized measurable disease site without metastasis (in principle a patient should have no embolized main portal vein, no marked A‐V shunt and A‐P shunt caused by tumor, but even though such conditions are detected if a clinical investigator decides that the patient is suitable for this study this principle is not applied). 3)A patient who does not have previous treatment (in principle 2‐week interval should be taken in case of 5‐FU, UFT, 5'‐DFUR, FUDR etc. or 4‐week interval should be taken in case of the other anti‐cancer drugs such as CDDP, MTX, DXR, EPI, MMC, ETP and radiation therapy). When there is no influence caused by pretreatment, details will not be asked about the pretreatment. 4)Performance Status(P.S.):0‐2 5)Child‐Pugh:A or B 6)The functions of main organs (bone mar
Epistemonikos ID: 593717f558493f5689c0c1b2d78a856ed47f954b
First added on: Aug 21, 2024