Condition category
Cancer
Date applied
30/03/2008
Date assigned
01/09/2008
Last edited
01/09/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Maoquan Li

ORCID ID

Contact details

YanChang Road
301
Shanghai
200072
China

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 measures

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

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

Sponsor information

Organisation

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

Sponsor details

YanChang Road
301
Shanghai
200072
China

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes