Primary Liver CancerNCT03178929
Effect of SAMe Treatment on Recurrence After Radical Treatment of Primary Hepatic Carcinoma
A study testing S-Adenosyl Methionine in people with Primary Liver Cancer, run by Beijing Insight Science & Technology Co. Ltd..
Trial summary
The aim of this study is to explore the effect of SAMe on recurrence after radical treatment of Primary liver cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Liver Cancer
- What is being tested?
- S-Adenosyl Methionine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2017to 31 Aug 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must sign the informed consent prior to the beginning of any study-related procedures;
- Patients diagnosed of Primary liver cancer;
- BCLC Stage：Stage 0、Stage A;
- Accept radical treatment;
Who cannot join
- With any other anti-cancer treatment before or after the surgery;
- Patients with extrahepatic metastasis;
- Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction;
- Subjects accepting other trial drugs or participating in other clinical trials;
- Female with pregnancy or during the lactation period.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized Controlled Study on the Effect of S-Adenosyl Methionine Treatment on Anti-tumor Recurrence After Radical Treatment of Primary Hepatic Carcinoma
The aim of this study is to explore the effect of SAMe on recurrence after radical treatment of Primary liver cancer.
Read the detailed description
Primary liver cancer is now a major health problem. In the worldwide, PLC is the fifth most common cancer in male, the seventh in female, and has the second highest rate to cause death for men . Although the recent advances in treatment of Primary liver cancer have significantly improved the prognosis of patients with Primary liver cancer, the overall survival rate is still unsatisfactory. One of the reasons for the poor prognosis of Primary liver cancer is its high rate of recurrence. Anti-relapse treatment remains a pressing work to do.
In recent years, some study reported that SAMe had an impact on promoting apoptosis and inhibiting the growth on breast cancer, colon cancer, gastric cancer and liver cancer in vitro and vivo.
In this study, we aim to examine whether SAMe have an effect on improving patients' recurrence after radical treatment of Primary liver cancer.
- Conditions
- Primary Liver Cancer
- Being tested
- S-Adenosyl Methionine
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-Adenosyl MethionineDrug
Also called SAMe
2000mg, po
| Study group | Role | What they receive |
|---|---|---|
| S-Adenosyl Methionine Treatment | Experimental | Patients will be treated with S-Adenosyl Methionine treatment after radical treatment.
2000mg, po Receives: Drug: S-Adenosyl Methionine |
| control group | No intervention | Patients will be treated without S-Adenosyl Methionine treatment after radical treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to tumor recurrence
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.
- First posted7 Jun 2017
- Study start1 Jul 2017 (estimated)
- Primary completion1 Jul 2020 (estimated)
- Study completion31 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Liver CancerStudies 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
- 207 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Insight Science & Technology Co. Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03178929
- Sponsor's protocol ID
- INW161116SAMe
- Status last verified
- Jun 2017
- First submitted
- 6 Jun 2017
- Last updated
- 7 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study on the Effect of S-Adenosyl Methionine Treatment on Anti-tumor Recurrence After Radical Treatment of Primary Hepatic Carcinoma
- ClinicalTrials.gov ID
- NCT03178929
- Acronym / sponsor ID
- INW161116SAMe
- Conditions
- Primary Liver Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 207 participants (estimated)
- Lead sponsor
- Beijing Insight Science & Technology Co. Ltd.University, hospital or other
- Study start
- 1 Jul 2017 (estimated)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 31 Aug 2020 (estimated)
- First posted
- 7 Jun 2017 (actual)
- 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 explore the effect of SAMe on recurrence after radical treatment of Primary liver cancer.
Detailed description
Primary liver cancer is now a major health problem. In the worldwide, PLC is the fifth most common cancer in male, the seventh in female, and has the second highest rate to cause death for men . Although the recent advances in treatment of Primary liver cancer have significantly improved the prognosis of patients with Primary liver cancer, the overall survival rate is still unsatisfactory. One of the reasons for the poor prognosis of Primary liver cancer is its high rate of recurrence. Anti-relapse treatment remains a pressing work to do.
In recent years, some study reported that SAMe had an impact on promoting apoptosis and inhibiting the growth on breast cancer, colon cancer, gastric cancer and liver cancer in vitro and vivo.
In this study, we aim to examine whether SAMe have an effect on improving patients' recurrence after radical treatment of Primary liver cancer.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S-Adenosyl Methionine Treatment | Experimental | Drug: S-Adenosyl MethioninePatients will be treated with S-Adenosyl Methionine treatment after radical treatment. 2000mg, po |
| control group | No intervention | –Patients will be treated without S-Adenosyl Methionine treatment after radical treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient must sign the informed consent prior to the beginning of any study-related procedures;
- Patients diagnosed of Primary liver cancer;
- BCLC Stage：Stage 0、Stage A;
- Accept radical treatment;
Key exclusion criteria (5 listed)
- With any other anti-cancer treatment before or after the surgery;
- Patients with extrahepatic metastasis;
- Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction;
- Subjects accepting other trial drugs or participating in other clinical trials;
- Female with pregnancy or during the lactation period.
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 |
|---|---|---|
| S-Adenosyl MethionineAlso: SAMe2000mg, po | Drug | S-Adenosyl Methionine Treatment |
Primary outcome
Time to tumor recurrence
Time frame: 2 years
1 secondary outcome
Overall survival
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2017.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing S-Adenosyl Methionine in people with Primary Liver Cancer, run by Beijing Insight Science & Technology Co. Ltd..
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 4 inclusion and 5 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 7 Jun 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yin ying Lu, MD (13301256799, luyinying1973@163.com), 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: 2 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 7 Jun 2017.