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

Primary Purpose

Hepatocellular Carcinoma

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
S-Adenosyl Methionine
Sponsored by
Eastern Hepatobiliary Surgery Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring S-Adenosyl Methionine, Recurrence

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Eastern hepatobilliary surgery hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

S-Adenosyl Methionine Treatment

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Time to tumor recurrence

Secondary Outcome Measures

Overall survival

Full Information

First Posted
October 23, 2015
Last Updated
March 30, 2016
Sponsor
Eastern Hepatobiliary Surgery Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02586285
Brief Title
Effect of S-Adenosyl Methionine Treatment on Recurrence After Curative Resection of Hepatocellular Carcinoma
Official Title
A Randomized Controlled Study on the Effect of S-Adenosyl Methionine Treatment on Anti-tumor Recurrence After Curative Resection of Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Hepatobiliary Surgery Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
S-Adenosyl Methionine, Recurrence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
S-Adenosyl Methionine Treatment
Arm Type
Active Comparator
Arm Description
Patients will be treated with S-Adenosyl Methionine treatment after curative resection.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients will be treated without S-Adenosyl Methionine treatment after curative resection.
Intervention Type
Drug
Intervention Name(s)
S-Adenosyl Methionine
Other Intervention Name(s)
H20090408
Intervention Description
500mg-1000mg,iv,qd
Primary Outcome Measure Information:
Title
Time to tumor recurrence
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shen Feng, MD
Phone
0086-021-25070805
Email
shenfengdfgd@yahoo.com.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Wang Kui, MD
Email
wangkuiykl@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shen Feng, MD
Organizational Affiliation
Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eastern hepatobilliary surgery hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200438
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shen Feng, MD
Phone
0086-021-25070805
Email
shenfengdfgd@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Yong Xia, Doctor
Phone
86-021-81875495
First Name & Middle Initial & Last Name & Degree
Shen Feng, MD

12. IPD Sharing Statement

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

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