Effect of SAMe Treatment on Recurrence After Radical Treatment of Primary Hepatic Carcinoma

June 6, 2017 updated by: Beijing Insight Science & Technology Co. Ltd.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

207

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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;

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: S-Adenosyl Methionine Treatment

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

2000mg, po
Drug: S-Adenosyl Methionine
2000mg, po
Other Names:
  • SAMe
No Intervention: control group
Patients will be treated without S-Adenosyl Methionine treatment after radical treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to tumor recurrence
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Insight Science & Technology Co. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2017

Primary Completion (Anticipated)

July 1, 2020

Study Completion (Anticipated)

August 31, 2020

Study Registration Dates

First Submitted

June 6, 2017

First Submitted That Met QC Criteria

June 6, 2017

First Posted (Actual)

June 7, 2017

Study Record Updates

Last Update Posted (Actual)

June 7, 2017

Last Update Submitted That Met QC Criteria

June 6, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INW161116SAMe

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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