NCT03178929

Brief Summary

The aim of this study is to explore the effect of SAMe on recurrence after radical treatment of Primary liver cancer.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
207

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2017

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

June 6, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 7, 2017

Completed
24 days until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

June 7, 2017

Status Verified

June 1, 2017

Enrollment Period

3 years

First QC Date

June 6, 2017

Last Update Submit

June 6, 2017

Conditions

Primary Liver Cancer

Outcome Measures

Primary Outcomes (1)

  • Time to tumor recurrence

    2 years

Secondary Outcomes (1)

  • Overall survival

    2 years

Study Arms (2)

S-Adenosyl Methionine Treatment

EXPERIMENTAL

Patients will be treated with S-Adenosyl Methionine treatment after radical treatment. 2000mg, po

Drug: S-Adenosyl Methionine

control group

NO INTERVENTION

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

Interventions

S-Adenosyl MethionineDRUG

2000mg, po

Also known as: SAMe
S-Adenosyl Methionine Treatment

Eligibility Criteria

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

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

S-Adenosylmethionine

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

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

Central Study Contacts

Yin ying Lu, MD

CONTACT

13301256799luyinying1973@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2017

First Posted

June 7, 2017

Study Start

July 1, 2017

Primary Completion

July 1, 2020

Study Completion

August 31, 2020

Last Updated

June 7, 2017

Record last verified: 2017-06