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Sustained release particle of 5-fluorouracil combining transcatheter arterial chemoinfusion to treat hepatocellular carcinoma with portal vein tumour thrombus

Sustained release particle of 5-fluorouracil (Sinofuan®) combining transcatheter arterial chemoinfusion to treat hepatocellular carcinoma with portal vein tumour thrombus: a randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN53149519
Enrollment
30
Registered
2008-09-01
Start date
2008-03-17
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular carcinoma/portal vein tumour thrombus Cancer Hepatocellular carcinoma

Interventions

1. Intervention: percutaneously implant the sustained release particle of 5-fluorouracil in the tumour thrombus and treat HCC with TAC 2. Control: single treatment of HCC with TAC For the interventio

Sponsors

Affiliated 10th People's Hospital of Tongji University (China)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: 1. Uncontrolled hypertension 2. Unstable angina 3. Arrhythmias requiring treatment 4. Myocardial infarction (MI) 5. Congestive heart failure or cardiomyopathy requiring treatment

Design outcomes

Primary

MeasureTime frame
1. Patient dies, measured at one month and six months 2. Disappearance of portal vein thrombus, measured at one month

Secondary

MeasureTime frame
1. Closure of portal vein lateral flow, measured at one and two months 2. Decreased size of thrombus less than or equal to 20% of original, measured at one month, two months, four months and six months

Countries

China

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026