Hepatocellular CarcinomaNCT02523053
Effect of Intraoperative Controlled Release 5-Fluorouracil Therapy on Recurrence in Hepatocellular Carcinoma Patients
A study testing Hepatectomy and 5-Fluorouracil in people with Hepatocellular Carcinoma and Recurrence, run by Eastern Hepatobiliary Surgery Hospital at 1 site in China.
Trial summary
The aim of this study is to confirmed the role of intraoperative controlled release 5-Fluorouracil therapy in the prevention of recurrence after surgery for HCC patients with high risk of preoperative prediction of microvascular invasion. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma, Recurrence
- What is being tested?
- Hepatectomy and 5-Fluorouracil
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- Apr 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients > 18 years and <=70 years of age
- Patients preoperatively diagnosed of hepatocellular carcinoma according to the criteria of American Association for the Study of Liver Diseases(AASLD)
- Within Milan criteria
- Nomogram score for MVI prediction >200
- Preoperative ECOG criteria score of 0-1
- Child-Pugh class A liver function
- No Anticancer treatment before surgery
Who cannot join
- Major portal/hepatic vein invasion
- Extrahepatic metastasis
- Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction,which may affect the treatment of liver cancer
- Lost to follow-up
- Patients participating in other clinical trials
- Patients refused to join our trial
- Pregnant and breast-feeding women
Trial locations and contacts
1 site in 1 country.
China1 site
Eastern hepatobilliary surgery hospital
Shanghai, Shanghai Municipality, 200438
About this study
Official title: A Randomized Controlled Study on the Effect of Intraoperative Controlled Release 5-Fluorouracil Therapy on Anti-tumor Recurrence in Hepatocellular Carcinoma Patients With High Risk of Microvascular Invasion Presence
The aim of this study is to confirmed the role of intraoperative controlled release 5-Fluorouracil therapy in the prevention of recurrence after surgery for HCC patients with high risk of preoperative prediction of microvascular invasion.
Read the detailed description
Surgical resection is the major curative treatment for patients with hepatocellular carcinoma (HCC). However, the postoperative 5-year recurrence rate after surgical resection was significantly high, which has been reported to 40%-70%.
Recurrence after surgery is the main factor affecting the efficacy of management of hepatocellular carcinoma, however, there are few methods for the prevention of recurrence and no standard treatment for recurrent HCC following curative-intent initial surgery has been established so far. The effective prevention of recurrence is the key to improve the management of HCC.
Previous studies showed the prevalence of microvascular invasion (MVI) in one of the critical and negative prognostic factors for HCC patients after partial hepatectomy or liver transplantation. For the early stage HCC patients, preoperative prediction of MVI is helpful to identify the appropriate object of anti-recurrence treatment before or after operation.
Our another previous study established a nomogram for MVI prediction of early HCC patients, which can preoperative efficiently predict the occurrence of MVI within Milan criteria, has been published online in JAMA surgery. On the other hand, there are only few studies reported the use of controlled release 5-Fluorouracil in the treatment of digestive tract tumors.
The action time of the controlled release 5-Fluorouracil particles is more than 15 days, the diffusion radius is 4-6cm. In theory, during the operation, the drug can be given to any location that may have tumor residues, timely and conveniently, and has a long time to maintain a high drug concentration, which is conducive to kill small metastatic foci caused by MVI. However, to our best knowledge, there is no evidence of high levels of evidence-based medical evidence to confirm the value of controlled release 5-Fluorouracil in the prevention of HCC recurrence.
In view of this, we aim to implement a randomized controlled study to confirmed the role of intraoperative controlled release 5-Fluorouracil therapy in the prevention of recurrence after surgery for HCC patients with high risk of preoperative prediction of microvascular invasion.
- Conditions
- Hepatocellular Carcinoma, Recurrence
- Being tested
- Hepatectomy, 5-Fluorouracil
- Keywords
- Hepatocellular Carcinoma, Recurrence, Microvascular Invasion, 5-Fluorouracil
- Medical subject headings
- Carcinoma, Hepatocellular, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HepatectomyProcedure or surgery
Surgical removal of all lesions
5-FluorouracilDrug
Surgical removal of all lesions and intraoperative controlled release 5-Fluorouracil therapy
| Study group | Role | What they receive |
|---|---|---|
| Hepatectomy | Active comparator | Surgical removal of all lesions Receives: Procedure: Hepatectomy |
| Hepatectomy plus 5-Fluorouracil | Experimental | Surgical removal of all lesions and intraoperative controlled release 5-Fluorouracil therapy Receives: Procedure: Hepatectomy; Drug: 5-Fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to tumor recurrence
Measured: 5 years
Secondary outcomes (1)
Overall survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study startApr 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Hepatobiliary Surgery Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ShenFeng, Eastern Hepatobiliary Surgery Hospital
- Investigators
- Shen Feng, MD, Study chair, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02523053
- Sponsor's protocol ID
- EHBHKY2015-01-011
- Status last verified
- Mar 2016
- First submitted
- 10 Aug 2015
- Last updated
- 21 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study on the Effect of Intraoperative Controlled Release 5-Fluorouracil Therapy on Anti-tumor Recurrence in Hepatocellular Carcinoma Patients With High Risk of Microvascular Invasion Presence
- ClinicalTrials.gov ID
- NCT02523053
- Acronym / sponsor ID
- EHBHKY2015-01-011
- Conditions
- Hepatocellular Carcinoma, Recurrence
- Keywords
- Hepatocellular Carcinoma, Recurrence, Microvascular Invasion, 5-Fluorouracil
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Eastern Hepatobiliary Surgery HospitalUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 14 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to confirmed the role of intraoperative controlled release 5-Fluorouracil therapy in the prevention of recurrence after surgery for HCC patients with high risk of preoperative prediction of microvascular invasion.
Detailed description
Surgical resection is the major curative treatment for patients with hepatocellular carcinoma (HCC). However, the postoperative 5-year recurrence rate after surgical resection was significantly high, which has been reported to 40%-70%.
Recurrence after surgery is the main factor affecting the efficacy of management of hepatocellular carcinoma, however, there are few methods for the prevention of recurrence and no standard treatment for recurrent HCC following curative-intent initial surgery has been established so far. The effective prevention of recurrence is the key to improve the management of HCC.
Previous studies showed the prevalence of microvascular invasion (MVI) in one of the critical and negative prognostic factors for HCC patients after partial hepatectomy or liver transplantation. For the early stage HCC patients, preoperative prediction of MVI is helpful to identify the appropriate object of anti-recurrence treatment before or after operation.
Our another previous study established a nomogram for MVI prediction of early HCC patients, which can preoperative efficiently predict the occurrence of MVI within Milan criteria, has been published online in JAMA surgery. On the other hand, there are only few studies reported the use of controlled release 5-Fluorouracil in the treatment of digestive tract tumors.
The action time of the controlled release 5-Fluorouracil particles is more than 15 days, the diffusion radius is 4-6cm. In theory, during the operation, the drug can be given to any location that may have tumor residues, timely and conveniently, and has a long time to maintain a high drug concentration, which is conducive to kill small metastatic foci caused by MVI. However, to our best knowledge, there is no evidence of high levels of evidence-based medical evidence to confirm the value of controlled release 5-Fluorouracil in the prevention of HCC recurrence.
In view of this, we aim to implement a randomized controlled study to confirmed the role of intraoperative controlled release 5-Fluorouracil therapy in the prevention of recurrence after surgery for HCC patients with high risk of preoperative prediction of microvascular invasion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hepatectomy | Active comparator | Procedure: HepatectomySurgical removal of all lesions |
| Hepatectomy plus 5-Fluorouracil | Experimental | Procedure: Hepatectomy, Drug: 5-FluorouracilSurgical removal of all lesions and intraoperative controlled release 5-Fluorouracil therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female patients > 18 years and <=70 years of age
- Patients preoperatively diagnosed of hepatocellular carcinoma according to the criteria of American Association for the Study of Liver Diseases(AASLD)
- Within Milan criteria
- Nomogram score for MVI prediction >200
- Preoperative ECOG criteria score of 0-1
Key exclusion criteria (7 listed)
- Major portal/hepatic vein invasion
- Extrahepatic metastasis
- Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction,which may affect the treatment of liver cancer
- Lost to follow-up
- Patients participating in other clinical trials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HepatectomySurgical removal of all lesions | Procedure or surgery | Hepatectomy, Hepatectomy plus 5-Fluorouracil |
| 5-FluorouracilSurgical removal of all lesions and intraoperative controlled release 5-Fluorouracil therapy | Drug | Hepatectomy plus 5-Fluorouracil |
Primary outcome
Time to tumor recurrence
Time frame: 5 years
1 secondary outcome
Overall survival
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shen Feng, MD study chair
Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hepatectomy and 5-Fluorouracil in people with Hepatocellular Carcinoma and Recurrence, run by Eastern Hepatobiliary Surgery Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shen Feng, MD (0086-021-25070805, shenfengdfgd@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to tumor recurrence (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2016.