advanced hepatocellular carcinoma
Conditions
Interventions
HAIC with DSM On day 1 and 7, cisplatin (50mg) is administered via the injection port. After that point, emulsion obtained by mixing DSM and contrast agent is injected until stasis and reflux are ach
Sponsors
Yamaguchi University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with advanced hepatocellular carcinoma 2) HCC without extrahepatic lesion 3) Patients who have no influence on previous treatment 4) Performance status(PS) 0 or 1 5) Child-Pugh A or B 6) Favorable function of major organs (bone marrow, kidney, heart), and meeting criteria as follows: (1) WBC >= 2500/mm3 (2) platelet count>= 50000/mm3 (3) hemogrobin level >= 9.0g/dl (4) total bilirubin <= 3.0mg/dl (5) serum creatinine level < 2mg/dl (6) BUN <= 25mg/dl (7) prothrombin time activity >= 50% 7) age >= 20years, male and female
Exclusion criteria
Exclusion criteria: 1) Severe coexisting illness (expect for chronic hepatitis or liver cirrhosis) 2) Active double cancers 3) Past history of hypersensitivity for drugs including iodine and contrast agent 4) Patients with pregnancy, lactation or possibility of pregnancy 5) Chronic respiratory failure 6) No hypersensitivity to DSM 7) Patients who judged as inadequacy due to other reasons by the doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Response, Survival, Progression-free survival | — |
Countries
Japan
Contacts
Public ContactIssei Saeki
Yamaguchi University Graduate School of Medicine Department of Gastroenterology and Hepatology
Outcome results
None listed