Hepatocellular CarcinomaNCT00817895

Intraoperative Chemotherapy Against Hepatocellular Carcinoma Recurrence

A study testing sustained released 5-FU and sustained released cisplatin, sustained released 5-FU and TACE in people with Hepatocellular Carcinoma, run by Eastern Hepatobiliary Surgery Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Hepatocellular Carcinoma
What is being tested?: sustained released 5-FU and sustained released cisplatin, sustained released 5-FU and TACE
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 150 participants
Where: 1 siteChina
Study dates: Dec 2008to Dec 2010
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

tumor >5cm;
multiple tumor located in one liver lobe;
margin of tumor is not clear;
cutting edge to tumor <1cm;
portal vein branch invasion;
without extra-liver metastasis;
patient's liver function and condition is able to accept hepatectomy.

Who cannot join

single tumor <=5cm;
multiple tumor located more than in one liver lobe;
margin of tumor is clear;
cutting edge to tumor >=1cm;
portal vein stem invasion
extra-liver metastasis;
patient's liver function and condition cannot accept hepatectomy.

Trial locations and contacts

1 site in 1 country.

China1 site

Eastern Hepatobiliary Surgery Hospital
Shanghai, Shanghai Municipality, 200438

Other trials in China

About this study

Official title: Clinical Randomized Control Trial of Intraoperative Implanting Chemotherapeutic Drugs Sustained Release Following Resection of Hepatocellular Carcinoma Against Postoperative Short-term Recurrence

Hepatectomy is still the most important treatment for HCC.High recurrence rate mostly influence it's prognosis, especially for the patient with tumor >5cm, multiple tumor and who cannot accept R0 resection.Our retrospective study showed sustained released 5-FU implanted into the liver incisal margin after tumor was resected could reduce the recurrence rate of HCC after liver resection.According to this, we proceed this RCT to prospectively observe the effect of sustained released 5-FU,and we also want to know whether combined with sustained released cisplatin will get better effect in preventing the tumor recurrence,especially in short time after liver resection.

Read the detailed description

150 HCC patients with tumor >5cm, multiple tumor and who cannot accept R0 resection will be randomized divided into 3 groups. Group A (50 cases) will be implanted 600mg sustained released 5-FU into liver incisal margin after tumor is resected. Group B (50 cases) will be implanted 600mg sustained released 5-FU and 60mg sustained released cisplatin. Group C (50 cases) will be the controlled one which will not be implanted any chemotherapeutic drugs. All patients will accepted TACE 30 days after liver resection. We will follow up all patients until they are dead or missed connected. Related adverse reaction will be recorded. Total survival time (TST) and disease free survival time (DFST) will be calculated too. At the end of the study we will compare the difference of adverse reaction, complication, TST and DFST between the 3 groups. According to the result we will estimate these drugs' antitumor effect and safety.

Conditions: Hepatocellular Carcinoma
Being tested: sustained released 5-FU and sustained released cisplatin, sustained released 5-FU, TACE
Keywords: hepatocellular carcinoma, liver resection, intraoperative chemotherapy
Medical subject headings: Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

sustained released 5-FU and sustained released cisplatinDrug
Also called 5-FU+Cisplatin group
600mg sustained released 5-FU and 60mg sustained released cisplatin will be implanted into liver incisal margin after tumor is resected.
sustained released 5-FUDrug
Also called 5-FU group
600mg sustained released 5-FU will be implanted into liver incisal margin after tumor is resected.
TACEProcedure or surgery
Also called Postoperative TACE
All patients will accept TACE one month after tumor was resected.

Study groups in NCT00817895
Study group	Role	What they receive
5-FU+Cisplatin	Experimental	50 HCC patients will be implanted 600mg sustained released 5-FU and 60mg sustained released cisplatin into liver incisal margin after tumor is resected. Receives: Drug: sustained released 5-FU and sustained released cisplatin; Procedure: TACE
5-FU	Active comparator	50 HCC patients will be implanted 600mg sustained released 5-FU into liver incisal margin after tumor is resected. Receives: Drug: sustained released 5-FU; Procedure: TACE
control	Experimental	Not described Receives: Procedure: TACE

What is being measured

The primary outcome is the main question the study is designed to answer.

disease free survival
Measured: 2 years

Secondary outcomes (1)

overall survival
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2008Dec 2010

First posted7 Jan 2009 (estimated)
Study startDec 2008
Primary completionDec 2009
Study completionDec 2010

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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00817895
Sponsor's protocol ID: EHBH-RCT-2008-010
Status last verified: Mar 2016
First submitted: 4 Jan 2009
Last updated: 31 Mar 2016
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hepatocellular Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Randomized Control Trial of Intraoperative Implanting Chemotherapeutic Drugs Sustained Release Following Resection of Hepatocellular Carcinoma Against Postoperative Short-term Recurrence
ClinicalTrials.gov ID: NCT00817895
Acronym / sponsor ID: EHBH-RCT-2008-010
Conditions: Hepatocellular Carcinoma
Keywords: hepatocellular carcinoma, liver resection, intraoperative chemotherapy
Study type: Interventional
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: Eastern Hepatobiliary Surgery HospitalUniversity, hospital or other
Study start: Dec 2008
Primary completion: Dec 2009 (actual)
Study completion: Dec 2010 (actual)
First posted: 7 Jan 2009 (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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
5-FU+Cisplatin	Experimental	Drug: sustained released 5-FU and sustained released cisplatin, Procedure: TACE50 HCC patients will be implanted 600mg sustained released 5-FU and 60mg sustained released cisplatin into liver incisal margin after tumor is resected.
5-FU	Active comparator	Drug: sustained released 5-FU, Procedure: TACE50 HCC patients will be implanted 600mg sustained released 5-FU into liver incisal margin after tumor is resected.
control	Experimental	Procedure: TACE

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

tumor >5cm;
multiple tumor located in one liver lobe;
margin of tumor is not clear;
cutting edge to tumor <1cm;
portal vein branch invasion;

Key exclusion criteria (7 listed)

single tumor <=5cm;
multiple tumor located more than in one liver lobe;
margin of tumor is clear;
cutting edge to tumor >=1cm;
portal vein stem invasion

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
sustained released 5-FU and sustained released cisplatinAlso: 5-FU+Cisplatin group600mg sustained released 5-FU and 60mg sustained released cisplatin will be implanted into liver incisal margin after tumor is resected.	Drug	5-FU+Cisplatin
sustained released 5-FUAlso: 5-FU group600mg sustained released 5-FU will be implanted into liver incisal margin after tumor is resected.	Drug	5-FU
TACEAlso: Postoperative TACEAll patients will accept TACE one month after tumor was resected.	Procedure or surgery	5-FU, 5-FU+Cisplatin, control

Primary outcome

disease free survival
Time frame: 2 years

1 secondary outcome

overall survival
Time frame: 2 years

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2016.

Related trials for Hepatocellular Carcinoma

RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
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Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
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RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
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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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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: finished, as of the sponsor's last update on 31 Mar 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

disease free survival (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00817895.

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 31 Mar 2016.