Hepatocellular CarcinomaNCT00838968
The Efficiency of Postoperative Interferon-alpha Treatment in p48 Positive Patients With Hepatocellular Carcinoma
A study testing interferon-alpha in people with Hepatocellular Carcinoma, run by Fudan University.
Trial summary
The purpose of the study is to determine whether interferon-alpha is effective in the treatment of p48 Positive patients with HCC after curative resection. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- interferon-alpha
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Jan 2013
- 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
- Patients with p48 Positive who underwent a curative resection of HCC
Who cannot join
- None
About this study
Official title: The Efficiency of Postoperative Interferon-alpha(IFNa) Treatment in p48 Positive Patients With Hepatocellular Carcinoma
The purpose of the study is to determine whether interferon-alpha is effective in the treatment of p48 Positive patients with HCC after curative resection.
Read the detailed description
BACKGROUND: Postoperative interferon-alpha (IFN-alpha) therapy improved survival in patients with hepatocellular carcinoma (HCC). P48 is a predictive marker for outcome of postoperative interferon-alpha treatment in patients with HCC. Our study is to identify the Efficiency of Postoperative IFN-Alpha Treatment in p48 Positive Patients With HCC.
METHODS: An immunohistochemical study of P48 was performed on specimens that were collected from patients who underwent a curative resection of HCC. These patient with p48 Positive were randomized divided into a treatment group who received postoperative IFN-alpha therapy and a comparison group who not received. Besides the side effect, the overall survival rate and the disease-free survival rate will be observed.
Anticipated RESULTS: IFN alpha treatment improved the overall survival of p48 Positive patients with HCC after curative resection, probably by postponing recurrence.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- interferon-alpha
- Keywords
- hepatocellular carcinoma, interferon-alpha, p48
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interferon-alphaDrug
Also called Recombinant Human Interferon α1b for Injection, SINOGEN
interferon-alpha is intramuscularly or subcutaneously injected at 3,000,000-5,000,000 U three times a week for 18 months
| Study group | Role | What they receive |
|---|---|---|
| interferon-alpha (IFN-alpha) | Active comparator | the interferon-alpha is intramuscular injected 3,000,000U three times a week for 18 months Receives: Drug: interferon-alpha |
| control | No intervention | no interventions were assigned |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-years survival rate
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 posted9 Feb 2009 (estimated)
- Study startJan 2008
- Primary completionOct 2012 (estimated)
- Study completionJan 2013 (estimated)
Why it stopped: we have found another marker (microRNA26) which is more sensitive to evaluate the effect of postoperative IFNa treatment in patients with HCC
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.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui-Chuan Sun, Fudan University
- Investigators
- Hui-chuan Sun, MD, Principal investigator, Liver Cancer Institute and Zhongshan Hospital, Fudan University, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00838968
- Sponsor's protocol ID
- LCI
- Status last verified
- Aug 2012
- First submitted
- 6 Feb 2009
- Last updated
- 23 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficiency of Postoperative Interferon-alpha(IFNa) Treatment in p48 Positive Patients With Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT00838968
- Acronym / sponsor ID
- LCI
- Conditions
- Hepatocellular Carcinoma
- Keywords
- hepatocellular carcinoma, interferon-alpha, p48
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: we have found another marker (microRNA26) which is more sensitive to evaluate the effect of postoperative IFNa treatment in patients with HCC
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 9 Feb 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.
The purpose of the study is to determine whether interferon-alpha is effective in the treatment of p48 Positive patients with HCC after curative resection.
Detailed description
BACKGROUND: Postoperative interferon-alpha (IFN-alpha) therapy improved survival in patients with hepatocellular carcinoma (HCC). P48 is a predictive marker for outcome of postoperative interferon-alpha treatment in patients with HCC. Our study is to identify the Efficiency of Postoperative IFN-Alpha Treatment in p48 Positive Patients With HCC.
METHODS: An immunohistochemical study of P48 was performed on specimens that were collected from patients who underwent a curative resection of HCC. These patient with p48 Positive were randomized divided into a treatment group who received postoperative IFN-alpha therapy and a comparison group who not received. Besides the side effect, the overall survival rate and the disease-free survival rate will be observed.
Anticipated RESULTS: IFN alpha treatment improved the overall survival of p48 Positive patients with HCC after curative resection, probably by postponing recurrence.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interferon-alpha (IFN-alpha) | Active comparator | Drug: interferon-alphathe interferon-alpha is intramuscular injected 3,000,000U three times a week for 18 months |
| control | No intervention | –no interventions were assigned |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with p48 Positive who underwent a curative resection of HCC
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| interferon-alphaAlso: Recombinant Human Interferon α1b for Injection, SINOGENinterferon-alpha is intramuscularly or subcutaneously injected at 3,000,000-5,000,000 U three times a week for 18 months | Drug | interferon-alpha (IFN-alpha) |
Primary outcome
5-years survival rate
Time frame: 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2012.
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)
Liver Neoplasms, Primary Liver Cancer
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
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
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.
Hui-chuan Sun, MD principal investigator
Liver Cancer Institute and Zhongshan Hospital, Fudan University, Shanghai, China
Questions about this trial
What is this clinical trial studying?
A study testing interferon-alpha in people with Hepatocellular Carcinoma, run by Fudan University.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 23 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
5-years survival rate (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 23 Aug 2012.