Balloon occluded transarterial chemoembolization using miriplatin in HCC: A Multicenter, Clinical Phase II study
Phase 2
- Conditions
- Hepatocellular carcinoma
- Registration Number
- JPRN-UMIN000029504
- Lead Sponsor
- The Japanese Society for Transcatheter Hepatic Arterial Embolization
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 52
Inclusion Criteria
Not provided
Exclusion Criteria
1) Bile duct injury(bile duct dilatation), reconstruction of the biliary tract history, history of endoscopic biliary treatment 2) Severe arterio-portal shunting 3) Severe arterial stenosis or obstruction in CECT or AAG 4) Severe ascites or pleural effusion 5) Major portal invation (Vp3 or Vp4) 6) Severe complication (cardiac failure, arrhythmia, angina pectoris, myocardial infarction within 6 months, double cancer, active infection, gastrointestinal bleeding, severe hepatic encephalopathy, severe allergya for contrast media or medicine) 7) Pregnant, nursing or possible pregnant woman 8) Qualified ineligible patients being this clinical trial by responsible doctor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate in largest tumor (3 months after treatment)
- Secondary Outcome Measures
Name Time Method Adverse events, progression-free survival, overall survival, response rate of HCC treated by B-TACE (3 months), achievement rate of B-TACE