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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02586285
• Other study ID #: EHBHKY2014-03-015
• Status: Recruiting
• Phase: Phase 1
• First received: October 23, 2015
• Last updated: March 30, 2016
• Start date: June 2015
• Est. completion date: December 2017

Study information

• Verified date: March 2016
• Source: Eastern Hepatobiliary Surgery Hospital
• Contact: Shen Feng, MD
• Phone: 0086-021-25070805
• Email: shenfengdfgd[@]yahoo.com.cn
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Recurrence

Intervention

Drug:
• S-Adenosyl Methionine
500mg-1000mg,iv,qd

Locations

Country	Name	City	State
China	Eastern hepatobilliary surgery hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Hepatobiliary Surgery Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to tumor recurrence		5 years	No
Secondary	Overall survival		5 years	No