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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03178929
Other study ID # INW161116SAMe
Secondary ID
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
Health authority
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.

Study Design


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
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