Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Sustained release particle of 5-fluorouracil (Sinofuan®) combining transcatheter arterial chemoinfusion to treat hepatocellular carcinoma with portal vein tumour thrombus: a randomised controlled trial
Acronym
Study hypothesis
The prognosis of patients with hepatocellular carcinoma (HCC) accompanied by portal vein tumour thrombus (PVTT) is generally poor. A literature review regarding transcatheter arterial chemoinfusion (TAC) was difficult due to differences in techniques, patient selection, and underlying liver function. In fact, this was an exclusion criterion for some treatments.
Sinofuan® is a newly approved fluorouracil sustained release particle for HCC in China. It can steadily release fluorouracil for hundreds of hours and maintains effective concentration around its implanting site. Because the portal vein tumour thrombus is mainly composed of tumour tissue, it is supposed that the direct implantation of Sinofuan® into the thrombus should result in a better outcome than single TAC therapy. This trial is designed to examine this hypothesis.
Ethics approval
Ethics approval received from the Ethics Committee of the Affiliated 10th People's Hospital, Tongji University (China) on the 5th March 2008.
Study design
Single-centre, non-blinded, randomised, controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Hepatocellular carcinoma/portal vein tumour thrombus
Intervention
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 intervention group, the sustained release particle of 5-fluorouracil will be percutaneously implanted once and only once. Within one week, TAC will be performed to treat HCC. The total duration of treatment will be no more than one week. The duration of follow-up is six months.
Intervention type
Drug
Phase
Not Specified
Drug names
5-fluorouracil (Sinofuan®)
Primary outcome measure
1. Patient dies, measured at one month and six months
2. Disappearance of portal vein thrombus, measured at one month
Secondary outcome measures
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
Overall trial start date
17/03/2008
Overall trial end date
30/09/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
30
Participant exclusion criteria
1. Uncontrolled hypertension
2. Unstable angina
3. Arrhythmias requiring treatment
4. Myocardial infarction (MI)
5. Congestive heart failure or cardiomyopathy requiring treatment
Recruitment start date
17/03/2008
Recruitment end date
30/09/2009
Locations
Countries of recruitment
China
Trial participating centre
YanChang Road, 301
Shanghai
200072
China
Funders
Funder type
Hospital/treatment centre
Funder name
Affiliated 10th People's Hospital of Tongji University (China)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list