HepatoCellular CarcinomaPhase 4SHOTNCT03024684
Statin for Preventing Hepatocellular Carcinoma Recurrence After Curative Treatment
A Phase 4 study testing Atorvastatin in people with HepatoCellular Carcinoma, run by Chiayi Christian Hospital at 6 sites in Taiwan.
Trial summary
The purpose of this study is to evaluate whether statin could prevent recurrence of hepatocellular carcinoma after curative treatment Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- HepatoCellular Carcinoma
- What is being tested?
- Atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 6 sitesTaiwan
- Study dates
- 3 Jan 2017to Jan 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals with HCC BCLC stage 0 or A who received curative radiofrequency ablation or hepatic resection could be eligible.
- Individuals who had single HCC (size > 5.0 cm) received hepatic resection would be eligible
- Individuals with prior history of HCC who had ever received curative ablation or hepatic resection without any recurrence for more than 2 years could be eligible if they had a new episode of recurrent HCC which could meet either of the former two criteria.
- After 12+/-1 weeks of curative treatment, eligible patients who have no evidence of local residual or recurrent tumors according to the dynamic CT or MRI could be enrolled
- The diagnosis of fresh HCC should be compatible with either pathological report or meet the criteria of AASLD guidelines
Who cannot join
- Undetermined nature of hepatic tumor
- HCC with extrahepatic metastasis or major vascular invasion
- With other malignant disease
- Child Pugh score >7
- Previous history of CAD event (angina, unstable angina, acute myocardial infarction) or ischemic stroke
- Hyperlipidemia or other indication for statin (according to Taiwan NHI guideline)
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- Advanced CKD (eGFR<30) or ESRD
- Severe comorbidity with life expectancy < 2 years
- Allergy to statin
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Taiwan6 sites
Ditmanson Medical Foundation Chiayi Christian Hospital
Chiayi City
E-DA Hospital
Kaohsiung City
Taichung Veterans General Hospital
Taichung
Tainan Municipal Hospital
Tainan
Mackay Memorial Hospital
Taipei
National Taiwan University Hospital Yun-Lin Branch
Yunlin
About this study
Official title: Statin for Preventing Hepatocellular Carcinoma Recurrence After Curative Treatment: a Double-blind Randomized Placebo-controlled Trial
The purpose of this study is to evaluate whether statin could prevent recurrence of hepatocellular carcinoma after curative treatment
Read the detailed description
This is a multi-center double-blind randomized placebo-controlled trial. A total of 240 patients with HCC at BCLC stage 0 or A will be enrolled from 8 hospitals in Taiwan. After complete ablation or hepatic resection of the tumor(s), participants are randomized 1:1 to receive either atorvastatin 10mg once daily (intervention group) or matched placebo (control group) for 3 years. During the 3-year period, patients are monitored for recurrence of HCC by dynamic computed tomography (or magnetic resonance image) every 4 months. They will be followed up until death, withdrawal from participation, study termination, or 3 years after the ablative treatment. The primary endpoint is to compare the 3-year cumulative incidence of recurrent HCC between the intervention group and control counterpart. Secondary endpoints are occurrence of clinical complications related to hepatic decompensation (including gastroesophageal variceal bleeding, spontaneous peritonitis, hepatic encephalopathy, hepatorenal syndrome, and hepatopulmonary syndrome), liver-related mortality, and all-cause mortality.
- Conditions
- HepatoCellular Carcinoma
- Being tested
- Atorvastatin, Placebo Oral Tablet
- Keywords
- Hepatocellular carcinoma, statin, curative ablation
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Atorvastatin 10mg daily
Placebo Oral TabletDrug
Placebo one tablet daily
| Study group | Role | What they receive |
|---|---|---|
| Statin | Experimental | Atorvastatin 10mg oral once daily Receives: Drug: Atorvastatin |
| Placebo | Placebo comparator | Matched placebo (sugar pill) once daily Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year cumulative incidence of recurrent HCC between the intervention group and control counterpart
Recurrence rate of HCC
Measured: 3 years
Secondary outcomes (1)
occurrence of clinical complications related to hepatic decompensation
clinical complications or hepatic decompensation
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2017 (estimated)
- Study start3 Jan 2017
- Primary completionJan 2025 (estimated)
- Study completionJan 2027 (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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiayi Christian Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- E-DA Hospital, National Taiwan University Hospital, Taichung Veterans General Hospital, Mackay Memorial Hospital, Tainan Municipal Hospital, National Cheng-Kung University Hospital, Chi Mei Medical Hospital
- Responsible party
- Sponsor
- Investigators
- Po Yueh Chen, Doctor, Principal investigator, Ditmanson Medical Foundation Chia-Yi Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03024684
- Sponsor's protocol ID
- 105005
- Acronym
- SHOT
- Status last verified
- Nov 2024
- First submitted
- 15 Jan 2017
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Statin for Preventing Hepatocellular Carcinoma Recurrence After Curative Treatment: a Double-blind Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT03024684
- Acronym / sponsor ID
- SHOT / 105005
- Conditions
- HepatoCellular Carcinoma
- Keywords
- Hepatocellular carcinoma, statin, curative ablation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Chiayi Christian HospitalUniversity, hospital or other
- Collaborators
- E-DA Hospital, National Taiwan University Hospital, Taichung Veterans General Hospital, Mackay Memorial Hospital, Tainan Municipal Hospital, National Cheng-Kung University Hospital, Chi Mei Medical Hospital
- Study start
- 3 Jan 2017 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 19 Jan 2017 (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 this study is to evaluate whether statin could prevent recurrence of hepatocellular carcinoma after curative treatment
Detailed description
This is a multi-center double-blind randomized placebo-controlled trial. A total of 240 patients with HCC at BCLC stage 0 or A will be enrolled from 8 hospitals in Taiwan. After complete ablation or hepatic resection of the tumor(s), participants are randomized 1:1 to receive either atorvastatin 10mg once daily (intervention group) or matched placebo (control group) for 3 years. During the 3-year period, patients are monitored for recurrence of HCC by dynamic computed tomography (or magnetic resonance image) every 4 months. They will be followed up until death, withdrawal from participation, study termination, or 3 years after the ablative treatment. The primary endpoint is to compare the 3-year cumulative incidence of recurrent HCC between the intervention group and control counterpart. Secondary endpoints are occurrence of clinical complications related to hepatic decompensation (including gastroesophageal variceal bleeding, spontaneous peritonitis, hepatic encephalopathy, hepatorenal syndrome, and hepatopulmonary syndrome), liver-related mortality, and all-cause mortality.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Statin | Experimental | Drug: AtorvastatinAtorvastatin 10mg oral once daily |
| Placebo | Placebo comparator | Drug: Placebo Oral TabletMatched placebo (sugar pill) once daily |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Individuals with HCC BCLC stage 0 or A who received curative radiofrequency ablation or hepatic resection could be eligible.
- Individuals who had single HCC (size > 5.0 cm) received hepatic resection would be eligible
- Individuals with prior history of HCC who had ever received curative ablation or hepatic resection without any recurrence for more than 2 years could be eligible if they had a new episode of recurrent HCC which could meet either of the former two criteria.
- After 12+/-1 weeks of curative treatment, eligible patients who have no evidence of local residual or recurrent tumors according to the dynamic CT or MRI could be enrolled
- The diagnosis of fresh HCC should be compatible with either pathological report or meet the criteria of AASLD guidelines
Key exclusion criteria (9 listed)
- Undetermined nature of hepatic tumor
- HCC with extrahepatic metastasis or major vascular invasion
- With other malignant disease
- Child Pugh score >7
- Previous history of CAD event (angina, unstable angina, acute myocardial infarction) or ischemic stroke
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 |
|---|---|---|
| AtorvastatinAtorvastatin 10mg daily | Drug | Statin |
| Placebo Oral TabletPlacebo one tablet daily | Drug | Placebo |
Primary outcome
3-year cumulative incidence of recurrent HCC between the intervention group and control counterpart
Time frame: 3 years
Recurrence rate of HCC
1 secondary outcome
occurrence of clinical complications related to hepatic decompensation
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- 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.
Po Yueh Chen, Doctor principal investigator
Ditmanson Medical Foundation Chia-Yi Christian Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atorvastatin in people with HepatoCellular Carcinoma, run by Chiayi Christian Hospital at 6 sites 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 5 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
3-year cumulative incidence of recurrent HCC between the intervention group and control counterpart (time frame: 3 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 12 Nov 2024.