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

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

Detailed Description
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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.

Official Title
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A Randomized Controlled Study on the Effect of S-Adenosyl Methionine Treatment on Anti-tumor Recurrence After Radical Treatment of Primary Hepatic Carcinoma

Conditions
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Primary Liver Cancer

Intervention / Treatment
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* Drug: S-Adenosyl Methionine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S-Adenosyl Methionine Treatment<br>Patients will be treated with S-Adenosyl Methionine treatment after radical treatment. 2000mg, po | Drug: S-Adenosyl Methionine<br>* 2000mg, po<br>* Other names: SAMe;|
| No Intervention: control group<br>Patients will be treated without S-Adenosyl Methionine treatment after radical treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to tumor recurrence |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 2 years |