malignant liver neoplasm in advanced stage
Conditions
Interventions
Establish isolated hepatic circulation using balloon catheters. Perform the procedure twice, more than 4 weeks apart. Initial dose is cisplatin 35mg/m2 and gemcitabin 300mg/m2 for cholangio carcinom
Sponsors
Nippon medical school
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Written informed consent 2 No indication of surgical resection 3 Apparent increase in tumor size documented within 3 months after chemotherapy 4 Performance status of 0-2 based on the Eastern Cooperative Oncology Group(ECOG) score 5 Acceptable renal function (serum creatinine concentration less than 1.2mg/dl) 6 Acceptable bone marrow function (leukocyte count of more than 3,500/mm3, platelet count of more than 50,000/mm3) 7 Total bilirubin is less than 3mg/dl
Exclusion criteria
Exclusion criteria: 1 Contraindication to angiography (due to severe side effect of contrast media) 2 High risk for general anesthesia 3 Advanced heart disease 4 Tumor invasion to Inferior vena cava or Portal vein trunk 5 Vascular anatomy not suitable for catheterization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse effect within 4 weeks after the procedure 5-year survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of the change in tumor burden 4 and 12 weeks after the procedure according to RECIST criteria | — |
Countries
Japan
Contacts
Public ContactSatoru Murata
Nippon medical school Department of Radiology
Outcome results
None listed