Sustained release particle of 5-fluorouracil combining transcatheter arterial chemoinfusion to treat hepatocellular carcinoma with portal vein tumour thrombus
Completed
- Conditions
- Hepatocellular carcinoma/portal vein tumour thrombusCancerHepatocellular carcinoma
- Registration Number
- ISRCTN53149519
- Lead Sponsor
- Affiliated 10th People's Hospital of Tongji University (China)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
1. Image-proven HCC
2. Irresectable tumour
3. Failure to previous treatment
4. Child-Pugh scale less than or equal to 10
5. Aged 30 - 80 years, either sex
6. Tumour thrombus is proven within portal vein and its section area exceeds 50% of vessel by computed tomography (CT)
Exclusion Criteria
1. Uncontrolled hypertension
2. Unstable angina
3. Arrhythmias requiring treatment
4. Myocardial infarction (MI)
5. Congestive heart failure or cardiomyopathy requiring treatment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Patient dies, measured at one month and six months<br>2. Disappearance of portal vein thrombus, measured at one month
- Secondary Outcome Measures
Name Time Method 1. Closure of portal vein lateral flow, measured at one and two months<br>2. Decreased size of thrombus less than or equal to 20% of original, measured at one month, two months, four months and six months