Liver metastases
Conditions
Interventions
Sponsors
Clinical Research Group of the Japanese Society for Transcatheter Hepatic Arterial Embolization
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or clinically confirmed liver metastases 2) Hypervascular 3) Treatment refractory 4) Max tumor can be evaluated with modified RECIST 5) Liver metastases seems to be the most important factor for prognosis 6) Child-Pugh class A 7) ECOG performance status: 0 or 1 8) Over 18 years old 9) Function of bone marrow, liver, and kidney are normal 10) Four weeks after the previous treatment 11) Expected survival time over 8 weeks 12) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Invasion to the portal vein (Vp3. Vp4) 2) History of the surgery or endoscopic treatment of the biliary tract 3) Treatment refractory pleural effusion or ascites 4) Severe arterioportal shunt or arteriovenous shunt 5) Severe stenosis or occlusion of the hepatic artery 6) History of the transcatheter arterial embolization/chemoembolization (TAE/TACE) using microsphere 7) Severe complication; heart failure, angina pectoris, arrhythmia, myocardial infarction active infection active gastrointestinal hemorrhage hepatic encephalopathy, mental disorder Iodine allergy, severe food allergy 8) Duplicate active cancer 9) Pregnant woman or woman who want to be pregnant 10) Qualified ineligible patients being this clinical trial by responsible doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate (1 month) | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety, Overall survival, Progression-free survival, Cancer type response rate | — |
Countries
Japan
Contacts
Public ContactMiyoko Suzuki
Nagoya City University Graduate School of Medical Sciences Clinical Research Management Center
Outcome results
None listed