Hepatocellular carcinoma
Conditions
Interventions
DDP-H is infused to the entire liver through a hepatic artery at a rate of 3mg/min in total of 35 mg/body surface area. After intrahepatic arterial infusion of DDP-H, chemolipiodolization using SM113
#8212
the dose to be taken into Phase II trials with the new agent. If two or more cases have already suffered from DLTs with the initial dose of DDP-H, the dose is reduced by 10 mg/body surface area down t
Sponsors
Niigata Hepatocellular Carcinoma Therapy Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically and/or clinically proven hepatocellular carcinoma except for mixed type. 2) Adequate for neither surgical resection nor puncture-based therapies. 3) There are bidimensionally measurable targets in the liver. 4) Age between 20 and 79 years old. 5) ECOG performance status score of 0-2. 6) Sufficient functional reserve of major organs. Neutrophil count : 1,500 /mm3 =< Platelet count : 50,000 /mm3 =< Hemoglobin : 8.0 g/dL =< Albumin : 3.0 g/dL =< Total bilirubin : 3.0 mg/dL => Total amylase in serum : 324 IU/bL => Creatinine clearance : 50ml/min =< (adjusted for 1.73m2 of body surface area) 7) Child-Pugh score of equal or less than 7. 8) An internal of 4 or more weeks after latest therapy against hepatocellular carcinoma. 9) A written informed consent from a patient him/her self.
Exclusion criteria
Exclusion criteria: 1) Pleural effusion and/or ascites refractory to treatments. 2) Comorbidity: Active infectious diseases except for hepatitis. Active bleeding from GI tract. Active concomitant cancer with invasive nature. Severe mental disorder or hepatic encephalopathy. 3) A history of severe allergic reaction against iodine contrast medium and/or platinum agents. 4) A pregnant or lactating female or female of childbearing age unless using effective contraception. 5) Ongoing interferon therapy. 6) Difficulties of oral intake. 7) Other serious conditions judged to be inadequate by a responsible doctor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) CBC, Coagulation factors 2) Basic biochemistry (TP, Alb, AST, ALT, ALP, LDH, GTP, T.Bil, D.Bil, BUN, Crt, Na, K, Cl, CRP) 3) Specific biochemistry (ChE, T.Chol, TG, HbA1c, NAG, beta-2-microgloblin) 4) Urinalysis 5) Retention time of ICG, Ccr | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Tumor marker (AFP, Fucosylated fraction of AFP, DCP) 2) Imaging evaluation of hepatocellular carcinoma 3) Serum concentratio of platinum | — |
Countries
Japan
Contacts
Public ContactMasato Igarashi
Niigata University Graduate School of Medical and Dental Sciences Department of Gastroenterology & Hepatology
Outcome results
None listed