HCCNCT02785874
Statin With Palliative Therapy for HCC
A study testing Statin in people with HCC, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial summary
Statin is a preventive medicine for hepatitis B and hepatitis C which decreases the risk turning into liver cancer,however, the investigators also discovered that patients taking Statin live longer than patients who didn't take Statin in the incidence of liver cancer death cases. Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- HCC
- What is being tested?
- Statin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2016to 1 Nov 2016
- 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 20 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >20 years old.
- BCLC stage B , stage C and stage D
Who cannot join
- Cancer diagnosis before HCC was confirmed and incurable.
- <20 years old, > 90years old.
- Patients who are judged to be ineligible for study entry by the investigator or subinvestigator
Trial locations and contacts
1 site in 1 country.
About this study
Statin is a preventive medicine for hepatitis B and hepatitis C which decreases the risk turning into liver cancer,however, the investigators also discovered that patients taking Statin live longer than patients who didn't take Statin in the incidence of liver cancer death cases.
Read the detailed description
Most liver cancer patients did not accept the cure as the main objective of the treatment after diagnosis because they choose alternative therapies palliative based, such as hepatic arterial chemoembolization, chemotherapy and radiation therapy.
Statin is a preventive medicine for hepatitis B and hepatitis C which decreases the risk turning into liver cancer, yet the clinical effect for Statin is still unknown.
In a previous study of 20,220 liver cancer patients in health care database, the investigators discovered that patients taking Statin live longer than patients who didn't take Statin in the incidence of liver cancer death cases.
This study is a continuation of previous health insurance database studies for clinical trials to verify whether Statin could prolong disease-free survival role for palliative treatment of liver cancer.
- Conditions
- HCC
- Being tested
- Statin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StatinDrug
Divide HCC patients into two groups under randomization, one is with Statin and the other is without Statin to verify whether Statin could prolong disease-free survival
| Study group | Role | What they receive |
|---|---|---|
| Statin(Crestor) taken | Experimental | Subjects take Statin(Crestor) 10mg per day for a- year Receives: Drug: Statin |
| non Statin(Crestor) taken | No intervention | non Statin(Crestor) taken as a reference for experimental group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: Up to two year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2016 (estimated)
- Study start1 Sep 2016
- Primary completion1 Oct 2016
- Study completion1 Nov 2016
Why it stopped: insufficient for the fund
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCCStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ming Shun Wu, Doctor, Study chair, WanFangHospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02785874
- Sponsor's protocol ID
- N201603038
- Status last verified
- May 2016
- First submitted
- 25 May 2016
- Last updated
- 19 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Statin With Palliative Therapy for HCC
- ClinicalTrials.gov ID
- NCT02785874
- Acronym / sponsor ID
- N201603038
- Conditions
- HCC
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient for the fund
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 1 Oct 2016 (actual)
- Study completion
- 1 Nov 2016 (actual)
- First posted
- 30 May 2016 (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.
Statin is a preventive medicine for hepatitis B and hepatitis C which decreases the risk turning into liver cancer,however, the investigators also discovered that patients taking Statin live longer than patients who didn't take Statin in the incidence of liver cancer death cases.
Detailed description
Most liver cancer patients did not accept the cure as the main objective of the treatment after diagnosis because they choose alternative therapies palliative based, such as hepatic arterial chemoembolization, chemotherapy and radiation therapy.
Statin is a preventive medicine for hepatitis B and hepatitis C which decreases the risk turning into liver cancer, yet the clinical effect for Statin is still unknown.
In a previous study of 20,220 liver cancer patients in health care database, the investigators discovered that patients taking Statin live longer than patients who didn't take Statin in the incidence of liver cancer death cases.
This study is a continuation of previous health insurance database studies for clinical trials to verify whether Statin could prolong disease-free survival role for palliative treatment of liver cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Statin(Crestor) taken | Experimental | Drug: StatinSubjects take Statin(Crestor) 10mg per day for a- year |
| non Statin(Crestor) taken | No intervention | –non Statin(Crestor) taken as a reference for experimental group. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- >20 years old.
- BCLC stage B , stage C and stage D
Key exclusion criteria (3 listed)
- Cancer diagnosis before HCC was confirmed and incurable.
- <20 years old, > 90years old.
- Patients who are judged to be ineligible for study entry by the investigator or subinvestigator
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 |
|---|---|---|
| StatinDivide HCC patients into two groups under randomization, one is with Statin and the other is without Statin to verify whether Statin could prolong disease-free survival | Drug | Statin(Crestor) taken |
Primary outcome
Overall Survival
Time frame: Up to two year
Results and safety
The study was stopped early (reason given: insufficient for the fund). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2017.
- Individual participant dataSharing planned: No
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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.
Ming Shun Wu, Doctor study chair
WanFangHospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Statin in people with HCC, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 19 Apr 2017. 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 Taiwan. 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 was stopped early (reason given: insufficient for the fund). Results are not available in the source record.
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?
Overall Survival (time frame: Up to two year). 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 19 Apr 2017.