Hepatocellular CarcinomaPhase 1NCT02586285
Effect of S-Adenosyl Methionine Treatment on Recurrence After Curative Resection of Hepatocellular Carcinoma
A Phase 1 study testing S-Adenosyl Methionine in people with Hepatocellular Carcinoma, run by Eastern Hepatobiliary Surgery Hospital at 1 site in China.
Trial summary
The aim of this study is to explore the effect of S-Adenosyl Methionine on recurrence after curative resection of Hepatocellular Carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- S-Adenosyl Methionine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Jun 2015to Dec 2017
- Phase
- Phase 1
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients > 18 years and <=70 years of age
- Patients preoperatively diagnosed of hepatocellular carcinoma according to the criteria of American Association for the Study of Liver Diseases(AASLD)
- Within Milan criteria
- Without or mild liver cirrhosis and the liver function is Child A class.
- Without any other treatments such as TACE、PEI、PRFA before the surgery
- No evidence for extrahepatic metastasis
Who cannot join
- Patients with macro tumor thrombus or extrahepatic metastasis.
- Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction.
- Subjects accepting other trial drugs or participating in other clinical trials.
- Patients refuse to join our trial.
- Female with pregnancy or during the lactation period.
Trial locations and contacts
1 site in 1 country.
Wang Kui, MD contact
China1 site, 1 recruiting
- Recruiting
Eastern hepatobilliary surgery hospital
Shanghai, Shanghai Municipality, 200438
Shen Feng, MD, 0086-021-25070805, shenfengdfgd@yahoo.com.cn
Yong Xia, Doctor, 86-021-81875495
About this study
Official title: A Randomized Controlled Study on the Effect of S-Adenosyl Methionine Treatment on Anti-tumor Recurrence After Curative Resection of Hepatocellular Carcinoma
The aim of this study is to explore the effect of S-Adenosyl Methionine on recurrence after curative resection of Hepatocellular Carcinoma.
Read the detailed description
Hepatocellular carcinoma (HCC) is now a major health problem. Although the recent advances in treatment of HCC have significantly improved the prognosis of patients with HCC, the overall survival rate is still unsatisfactory; the 5-year survival rate is only 50-70% even after curative treatment such as hepatic resection and percutaneous radiofrequency ablation. One of the reasons for the poor prognosis of HCC is its high rate of recurrence.However,anti-relapse treatment remains a pressing work to do.
In recent years, some study reported that S-Adenosyl Methionine 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 S-Adenosyl Methionine have an effect on improving patients' recurrence after curative resection of Hepatocellular Carcinoma.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- S-Adenosyl Methionine
- Keywords
- S-Adenosyl Methionine, Recurrence
- Medical subject headings
- Carcinoma, Hepatocellular, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-Adenosyl MethionineDrug
Also called H20090408
500mg-1000mg,iv,qd
| Study group | Role | What they receive |
|---|---|---|
| S-Adenosyl Methionine Treatment | Active comparator | Patients will be treated with S-Adenosyl Methionine treatment after curative resection. Receives: Drug: S-Adenosyl Methionine |
| Control group | No intervention | Patients will be treated without S-Adenosyl Methionine treatment after curative resection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to tumor recurrence
Measured: 5 years
Secondary outcomes (1)
Overall survival
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 posted26 Oct 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Hepatobiliary Surgery Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ShenFeng, Eastern Hepatobiliary Surgery Hospital
- Investigators
- Shen Feng, MD, Principal investigator, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02586285
- Sponsor's protocol ID
- EHBHKY2014-03-015
- Status last verified
- Mar 2016
- First submitted
- 23 Oct 2015
- Last updated
- 1 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2016. 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 Curative Resection of Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT02586285
- Acronym / sponsor ID
- EHBHKY2014-03-015
- Conditions
- Hepatocellular Carcinoma
- Keywords
- S-Adenosyl Methionine, Recurrence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Eastern Hepatobiliary Surgery HospitalUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 26 Oct 2015 (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 aim of this study is to explore the effect of S-Adenosyl Methionine on recurrence after curative resection of Hepatocellular Carcinoma.
Detailed description
Hepatocellular carcinoma (HCC) is now a major health problem. Although the recent advances in treatment of HCC have significantly improved the prognosis of patients with HCC, the overall survival rate is still unsatisfactory; the 5-year survival rate is only 50-70% even after curative treatment such as hepatic resection and percutaneous radiofrequency ablation. One of the reasons for the poor prognosis of HCC is its high rate of recurrence.However,anti-relapse treatment remains a pressing work to do.
In recent years, some study reported that S-Adenosyl Methionine 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 S-Adenosyl Methionine have an effect on improving patients' recurrence after curative resection of Hepatocellular Carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S-Adenosyl Methionine Treatment | Active comparator | Drug: S-Adenosyl MethioninePatients will be treated with S-Adenosyl Methionine treatment after curative resection. |
| Control group | No intervention | –Patients will be treated without S-Adenosyl Methionine treatment after curative resection. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patients > 18 years and <=70 years of age
- Patients preoperatively diagnosed of hepatocellular carcinoma according to the criteria of American Association for the Study of Liver Diseases(AASLD)
- Within Milan criteria
- Without or mild liver cirrhosis and the liver function is Child A class.
- Without any other treatments such as TACE、PEI、PRFA before the surgery
Key exclusion criteria (5 listed)
- Patients with macro tumor thrombus or extrahepatic metastasis.
- Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction.
- Subjects accepting other trial drugs or participating in other clinical trials.
- Patients refuse to join our trial.
- 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: H20090408500mg-1000mg,iv,qd | Drug | S-Adenosyl Methionine Treatment |
Primary outcome
Time to tumor recurrence
Time frame: 5 years
1 secondary outcome
Overall survival
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2016.
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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.
Wang Kui, MD contact
Shen Feng, MD principal investigator
Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing S-Adenosyl Methionine in people with Hepatocellular Carcinoma, run by Eastern Hepatobiliary Surgery Hospital at 1 site in China.
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 6 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 1 Apr 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Shen Feng, MD (0086-021-25070805, shenfengdfgd@yahoo.com.cn), 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: 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 1 Apr 2016.