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
About this trial
This is an interventional prevention trial for Primary Liver Cancer
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.
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
NCT ID
NCT03178929
First Posted
June 6, 2017
Last Updated
June 6, 2017
Sponsor
Beijing Insight Science & Technology Co. Ltd.
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
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Effect of SAMe Treatment on Recurrence After Radical Treatment of Primary Hepatic Carcinoma
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