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
Scientific
YanChang Road, 301
Shanghai
200072
China
Study information
| Study design | Single-centre, non-blinded, randomised, controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | 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(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) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 17/03/2008 |
| Completion date | 30/09/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 30 |
| Key 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) |
| Key exclusion criteria | 1. Uncontrolled hypertension 2. Unstable angina 3. Arrhythmias requiring treatment 4. Myocardial infarction (MI) 5. Congestive heart failure or cardiomyopathy requiring treatment |
| Date of first enrolment | 17/03/2008 |
| Date of final enrolment | 30/09/2009 |
Locations
Countries of recruitment
- China
Study participating centre
YanChang Road, 301
Shanghai
200072
China
200072
China
Sponsor information
Affiliated 10th People's Hospital of Tongji University (China)
Hospital/treatment centre
Hospital/treatment centre
YanChang Road, 301
Shanghai
200072
China
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
