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

ISRCTN ISRCTN53149519
DOI https://doi.org/10.1186/ISRCTN53149519
Secondary identifying numbers N/A
Submission date
30/03/2008
Registration date
01/09/2008
Last edited
01/09/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Maoquan Li
Scientific

YanChang Road, 301
Shanghai
200072
China

Study information

Study designSingle-centre, non-blinded, randomised, controlled study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleSustained release particle of 5-fluorouracil (Sinofuan®) combining transcatheter arterial chemoinfusion to treat hepatocellular carcinoma with portal vein tumour thrombus: a randomised controlled trial
Study objectivesThe 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(s)Ethics approval received from the Ethics Committee of the Affiliated 10th People's Hospital, Tongji University (China) on the 5th March 2008.
Health condition(s) or problem(s) studiedHepatocellular carcinoma/portal vein tumour thrombus
Intervention1. 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)5-fluorouracil (Sinofuan®)
Primary outcome measure1. Patient dies, measured at one month and six months
2. Disappearance of portal vein thrombus, measured at one month
Secondary outcome measures1. 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 study start date17/03/2008
Completion date30/09/2009

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants30
Key inclusion criteria1. 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)
Key exclusion criteria1. Uncontrolled hypertension
2. Unstable angina
3. Arrhythmias requiring treatment
4. Myocardial infarction (MI)
5. Congestive heart failure or cardiomyopathy requiring treatment
Date of first enrolment17/03/2008
Date of final enrolment30/09/2009

Locations

Countries of recruitment

  • China

Study participating centre

YanChang Road, 301
Shanghai
200072
China

Sponsor information

Affiliated 10th People's Hospital of Tongji University (China)
Hospital/treatment centre

YanChang Road, 301
Shanghai
200072
China

ROR logo "ROR" https://ror.org/03vjkf643

Funders

Funder type

Hospital/treatment centre

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan