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

Primary Liver Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03178929
• Other study ID #: INW161116SAMe
• Status: Not yet recruiting
• Phase: N/A
• First received: June 6, 2017
• Last updated: June 6, 2017
• Start date: July 1, 2017
• Est. completion date: August 31, 2020

Study information

• Verified date: June 2017
• Source: Beijing Insight Science & Technology Co. Ltd.
• Contact: Yin ying Lu, MD
• Phone: 13301256799
• Email: luyinying1973[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 207
• Est. completion date: August 31, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Liver Neoplasms
• Primary Liver Cancer
• Recurrence

Intervention

Drug:
• S-Adenosyl Methionine
2000mg, po

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Insight Science & Technology Co. Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to tumor recurrence		2 years
Secondary	Overall survival		2 years