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Status unknownNCT02586285Updated Apr 1, 2016

Effect of S-Adenosyl Methionine Treatment on Recurrence After Curative Resection of Hepatocellular Carcinoma

A Phase 1 interventional study of S-Adenosyl Methionine in Hepatocellular Carcinoma, sponsored by Eastern Hepatobiliary Surgery Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-04-01.

Sponsored by Eastern Hepatobiliary Surgery Hospital · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Hepatocellular Carcinoma

Keywords

  • S-Adenosyl Methionine
  • Recurrence
03

In context

Carcinoma, Hepatocellular

3,249 studies on the registry are indexed under Carcinoma, Hepatocellular; 974 are open to participants now.

This study's planned enrollment of 300 is above the median of 55 across 2,347 interventional studies indexed under Carcinoma, Hepatocellular.

Browse Carcinoma, Hepatocellular studies →

Lead sponsor

Eastern Hepatobiliary Surgery Hospital is the lead sponsor of 69 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Active comparator
    S-Adenosyl Methionine Treatment

    Patients will be treated with S-Adenosyl Methionine treatment after curative resection.

    Drug: S-Adenosyl Methionine

  • No intervention
    Control group

    Patients will be treated without S-Adenosyl Methionine treatment after curative resection.

Interventions

06

What researchers measure

Primary outcomes

  1. Time to tumor recurrence

    Time frame: 5 years

Secondary outcomes

  1. Overall survival

    Time frame: 5 years

07

Study locations

1 of 1 sites recruiting
  • Eastern hepatobilliary surgery hospital
    Shanghai, Shanghai Municipality 200438, China
    • Shen Feng, MD · Contact · shenfengdfgd@yahoo.com.cn · 0086-021-25070805
    • Yong Xia, Doctor · Contact · 86-021-81875495
    • Shen Feng, MD · Principal investigator
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2015, a primary completion of Dec 2017 and a completion of Dec 2017. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 23, 2015
First posted
Oct 26, 2015
Start
Jun 2015
Primary completionEst.
Dec 2017
CompletionEst.
Dec 2017
Last update
Apr 1, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 1, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02586285
Lead sponsor
Eastern Hepatobiliary Surgery Hospital
Responsible party
ShenFeng (vice president of the Eastern Hepatobiliary Surgery Hospital, Eastern Hepatobiliary Surgery Hospital) — Principal investigator
First posted
Oct 26, 2015
Start date
Jun 2015
Primary completion
Dec 2017 (estimated)
Completion
Dec 2017 (estimated)
Last update
Apr 1, 2016

Study contacts

Shen Feng, MD
Contact
shenfengdfgd@yahoo.com.cn
0086-021-25070805
Wang Kui, MD
Contact
wangkuiykl@163.com
Shen Feng, MD
principal investigator · Eastern Hepatobiliary Surgery Hospital, Second Military Medical University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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