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

NCT ID: NCT03178929

Last Updated: 2017-06-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 207 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2020-08-31

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.

Conditions

Primary Liver Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

S-Adenosyl Methionine Treatment

Patients will be treated with S-Adenosyl Methionine treatment after radical treatment.

2000mg, po

Group Type: EXPERIMENTAL

S-Adenosyl Methionine

Intervention Type: DRUG

2000mg, po

control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

S-Adenosyl Methionine

2000mg, po

Intervention Type: DRUG

Other Intervention Names

SAMe

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Insight Science & Technology Co. Ltd.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Yin ying Lu, MD

Role: CONTACT

luyinying1973@163.com

13301256799

Other Identifiers

INW161116SAMe

Identifier Type: -

Identifier Source: org_study_id