Hepatocellular carcinoma
Conditions
Interventions
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 arte
Sponsors
Department of Internal Medicine Keio University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
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 marrow, kidney, heart) should be maintained sufficiently and the clinical laboratory test results should fulfill the following conditions of the standard. Leukocytes:&#8805;3000/mm3,Platelets:&#8805;50000/mm3,Hemoglobin:&#8805;9.5g/dl,Creatinine:&#8804;upper limit of normal value of our institute,BUN:&#8804;25mg/dl,PT:&#8805;50%,Total bilirubin:<2 The above mentioned clinical laboratory tests should be performed 2 weeks before the registration. 7)Sex:regardless of sex 8)Age:not lower than 20 years old and below 80 years old 9)A patients whose life expectancy is more than 2 months and in principle who can be in a hospital during the observation period.
Exclusion criteria
Exclusion criteria: 1)A patient who has severe complications (however chronic hepatitis and liver cirrhosis are excluded for this criteria). 2)A patient who has active double cancers (besides HCC, the double cancers which can decide the prognosis). 3)A patient who has a medical history of severe hyperesthesia. 4)A patient who is pregnant, a nursing mother or is suspected of being pregnant. 5)A patient who is decided by the principal investigator or a clinical investigator not to be an adequate subject for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Survival rate and local-relapse-free survival/QOL survey | — |
Countries
Japan
Contacts
Public ContactShinichiro Tada
Keio University School of Medicine Department of Internal Medicine
Outcome results
None listed