NCT02586285

Brief Summary

The aim of this study is to explore the effect of S-Adenosyl Methionine on recurrence after curative resection of Hepatocellular Carcinoma.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_1 hepatocellular-carcinoma

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 26, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 1, 2016

Status Verified

March 1, 2016

Enrollment Period

2.5 years

First QC Date

October 23, 2015

Last Update Submit

March 30, 2016

Conditions

Hepatocellular Carcinoma

Keywords

S-Adenosyl MethionineRecurrence

Outcome Measures

Primary Outcomes (1)

  • Time to tumor recurrence

    5 years

Secondary Outcomes (1)

  • Overall survival

    5 years

Study Arms (2)

S-Adenosyl Methionine Treatment

ACTIVE COMPARATOR

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

Drug: S-Adenosyl Methionine

Control group

NO INTERVENTION

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

Interventions

S-Adenosyl MethionineDRUG

500mg-1000mg,iv,qd

Also known as: H20090408
S-Adenosyl Methionine Treatment

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern hepatobilliary surgery hospital

Shanghai, Shanghai Municipality, 200438, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, HepatocellularRecurrence

Interventions

S-Adenosylmethionine

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MethionineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAdenosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsAmino AcidsAmino Acids, Peptides, and ProteinsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • Shen Feng, MD

    Eastern Hepatobiliary Surgery Hospital, Second Military Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shen Feng, MD

CONTACT

0086-021-25070805shenfengdfgd@yahoo.com.cn

Wang Kui, MD

CONTACT

wangkuiykl@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
vice president of the Eastern Hepatobiliary Surgery Hospital

Study Record Dates

First Submitted

October 23, 2015

First Posted

October 26, 2015

Study Start

June 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

April 1, 2016

Record last verified: 2016-03

Locations

CN(1)