Unresectable hepatocellular carcinoma.
Conditions
Interventions
Make Miriplatin-Lipiodol suspension and infuse it into hepatic artery, followed by Gelpart infusion
Make Cisplatin-Lipiodol suspension and infuse it into hepatic artery, followed by Gelpart infusion
Sponsors
Japan community health care organization hitoyoshi medical center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histological proven or clinically diagnosed hepatocellular carcinoma. All cases are contraindication for resection and local treatment such as RFA and MCT. All cases have the localized measurable lesion. 2) Limited to liver (Tany, N0, M0) 3) Initial case of hepatocellular carcinoma or recurrence in the different region after treatment such as resection, RFA, PEIT, and TACE. 4) At least 4weeks interval is required after the initial treatment of resection, RFA and PEIT. 5) At least 3months interval is required after the initial TACE. 6) Performance Status: 0-2 7) Preserved liver function (Child-Pugh class A or B) 8) Preserved function of main organs (bone marrow, kidney, and heart) and fulfill all of the selected criteria below. i) T-Bill : =<2.0mg/dl ii) WBC : >=3000/mm3 iii) PLT : >=5x10^4/mm3 iv) Hb : >= 9.0g/dl v) Cre: =<1.3mg/ml(Cre:1.5mg/ml and eGFR>=30ml/min/1.7) vi) BUN : =<25mg/dl The above mentioned clinical tests should be performed within 2weeks before the registration. 9) Age >=20 yrs. 10) Written informed consent should be obtained.
Exclusion criteria
Exclusion criteria: 1) Tumor thrombus in the main portal vein(VP4). 2) Remarkable arterio-portal shunt and arterio-venous shunt. 3) Uncontrollable ascites or pleural effusion. 4) Previous medical history of severe hypersensitivity. 5) Previous history of treatment using Cisplatin(IA-call) or Miriplatin(MILIPLA). 6) Serious complications as described below (Except chronic hepatitis and liver cirrhosis) i) Severe heart disease ii) Myocardial infarction within 6months iii) Renal failure iv) Active infection except viral hepatitis v) Active bleeding from the digestive tract vi) Another active cancers (besides hepatocellular carcinoma, the double cancers which can decide the prognosis). vii) Hepatic encephalopathy or severe psychiatric disease. 7) Pregnant women and women suspected of being pregnant. 8) Patients who are concluded to be inappropriate to participate in this study by the lead investigator and other physicians in charge.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| effica(RR:Response Rate,DCR:Disease Control Rate) | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events Overall survival Local recurrence after the complete regression TTF:Time to treatment failure | — |
Countries
Japan
Contacts
Public ContactYuri Iwasaki
Japan community health care organization hitoyoshi medical center Clinical research center
Outcome results
None listed