Effect of S-Adenosyl Methionine Treatment on Recurrence After Curative Resection of Hepatocellular Carcinoma

Study Overview
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Brief Summary
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The aim of this study is to explore the effect of S-Adenosyl Methionine on recurrence after curative resection of Hepatocellular Carcinoma.

Detailed Description
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Hepatocellular carcinoma (HCC) is now a major health problem. Although the recent advances in treatment of HCC have significantly improved the prognosis of patients with HCC, the overall survival rate is still unsatisfactory; the 5-year survival rate is only 50-70% even after curative treatment such as hepatic resection and percutaneous radiofrequency ablation. One of the reasons for the poor prognosis of HCC is its high rate of recurrence.However,anti-relapse treatment remains a pressing work to do. In recent years, some study reported that S-Adenosyl Methionine 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 S-Adenosyl Methionine have an effect on improving patients' recurrence after curative resection of Hepatocellular Carcinoma.

Official Title
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A Randomized Controlled Study on the Effect of S-Adenosyl Methionine Treatment on Anti-tumor Recurrence After Curative Resection of Hepatocellular Carcinoma

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Drug: S-Adenosyl Methionine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients > 18 years and <=70 years of age Patients preoperatively diagnosed of hepatocellular carcinoma according to the criteria of American Association for the Study of Liver Diseases(AASLD) Within Milan criteria Without or mild liver cirrhosis and the liver function is Child A class. Without any other treatments such as TACE、PEI、PRFA before the surgery No evidence for extrahepatic metastasis Exclusion Criteria: Patients with macro tumor thrombus or extrahepatic metastasis. Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction. Subjects accepting other trial drugs or participating in other clinical trials. Patients refuse to join our trial. Female with pregnancy or during the lactation period.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: S-Adenosyl Methionine Treatment<br>Patients will be treated with S-Adenosyl Methionine treatment after curative resection. | Drug: S-Adenosyl Methionine<br>* 500mg-1000mg,iv,qd<br>* Other names: H20090408;|
| No Intervention: Control group<br>Patients will be treated without S-Adenosyl Methionine treatment after curative resection. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to tumor recurrence |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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S-Adenosyl Methionine, Recurrence