search
Back to results

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

Primary Purpose

Primary Liver Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
S-Adenosyl Methionine
Sponsored by
Beijing Insight Science & Technology Co. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Primary Liver Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    S-Adenosyl Methionine Treatment

    control group

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Time to tumor recurrence

    Secondary Outcome Measures

    Overall survival

    Full Information

    First Posted
    June 6, 2017
    Last Updated
    June 6, 2017
    Sponsor
    Beijing Insight Science & Technology Co. Ltd.
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03178929
    Brief Title
    Effect of SAMe Treatment on Recurrence After Radical Treatment of Primary Hepatic Carcinoma
    Official Title
    A Randomized Controlled Study on the Effect of S-Adenosyl Methionine Treatment on Anti-tumor Recurrence After Radical Treatment of Primary Hepatic Carcinoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 1, 2017 (Anticipated)
    Primary Completion Date
    July 1, 2020 (Anticipated)
    Study Completion Date
    August 31, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Beijing Insight Science & Technology Co. Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Primary Liver Cancer

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    207 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    S-Adenosyl Methionine Treatment
    Arm Type
    Experimental
    Arm Description
    Patients will be treated with S-Adenosyl Methionine treatment after radical treatment. 2000mg, po
    Arm Title
    control group
    Arm Type
    No Intervention
    Arm Description
    Patients will be treated without S-Adenosyl Methionine treatment after radical treatment.
    Intervention Type
    Drug
    Intervention Name(s)
    S-Adenosyl Methionine
    Other Intervention Name(s)
    SAMe
    Intervention Description
    2000mg, po
    Primary Outcome Measure Information:
    Title
    Time to tumor recurrence
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    Overall survival
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yin ying Lu, MD
    Phone
    13301256799
    Email
    luyinying1973@163.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs