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

Phase 1

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: S-Adenosyl Methionine

• Registration Number: NCT02586285
• Lead Sponsor: Eastern Hepatobiliary Surgery Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-10-23
• Study First Submitted QC: 2015-10-23
• Study First Posted: 2015-10-26
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-30
• Last Update Posted: 2016-04-01
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

• 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 curative resection.

Primary Outcome Measures

Name	Time	Method
Time to tumor recurrence	5 years

Secondary Outcome Measures

Name	Time	Method
Overall survival	5 years

Trial Locations

Locations (1)

Eastern hepatobilliary surgery hospital; 🇨🇳 Shanghai, Shanghai, China