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

Not Applicable

• Conditions: Primary Liver Cancer
• Interventions: Drug: S-Adenosyl Methionine

• Registration Number: NCT03178929
• Lead Sponsor: Beijing Insight Science & Technology Co. Ltd.

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.

Study Timeline

• Status Verified: 2017-06
• Study First Submitted: 2017-06-06
• Study First Submitted QC: 2017-06-06
• Last Update Submitted: 2017-06-06
• Study First Posted: 2017-06-07
• Last Update Posted: 2017-06-07
• Study Start: 2017-07-01
• Primary Completion: 2020-07-01
• Study Completion: 2020-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 207

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Time to tumor recurrence	2 years

Secondary Outcome Measures

Name	Time	Method
Overall survival	2 years