Hepatocellular carcinoma
Conditions
Interventions
SM11355
SM11355 after intrahepatic infusion of DDP-H
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) Local managements are difficult by surgical resection, puncture-based therapies, radiation therapy or transcatheter arterial chemoembolization. 3) No indication or consent for liver transplantation. 4) Indication for lipiodolization using SM11355 and intrahepatic arterial infusion of DDP-H. 5) No additional treatments will be performed targeting the lesions for SM11355. 6) In the area where SM11355 is going to be infused, there are target lesions larger than 10mm, which can be measured using CT and/or MRI. 7) Age over 20 years old. 8) ECOG performance status score of 0-2. 9) Sufficient functional reserve of major organs as indicated below. >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) 10) Child-Pugh score of equal or less than 8. 11) An interval of 4 or more weeks after any latest therapy against hepatocellular carcinoma. 12) A written informed consent from a patient himself/herself.
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 |
|---|---|
| Tiem to progression | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival | — |
Countries
Japan
Contacts
Public ContactTakeshi Suda
Uonuma Institute of Community Medicine, Niigata Medical and Dental Hospital Department of Gastroenterology & Hepatology
Outcome results
None listed