NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Hepatocellular carcinoma
Date of first enrollment	12/09/2005
Target sample size
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : SM-11355 (Miriplatin Hydrate) INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Intra-arterially injection

Outcome(s)

Primary Outcome	Efficacy: TEVrate (TE: therapeutic effect, the criteria for evaluation of direct effects on liver carcinoma, prepared by the Committee for Preparing Criteria for Evaluating the Effects of Multidisciplinary Treatment of Liver Cancer of the Japanese Society of Liver Carcinoma)
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	<= 74age old
Gender	Both
Include criteria	<Inclusion criteria> -HCC confirmed histologically and/or clinically diagnosed by angiography and CT -Hypervascular HCC -Not indicated for hepatectomy, PEI, PMCT and RFA -Stage II or III (Liver Cancer Study Group of Japan: Classification of primary liver cancer) -ECOG performance status (PS) of 0, 1 or 2 -Aged 20 to less than 75 etc. <Exclusion criteria> -Patients with a history of severe allergy to iodine-containing drugs and/or contrast media -Severe complication (especially severe thyroid or heart disease) -Active malignancies of other organs etc.
Exclude criteria