Postoperative Adjuvant TACE Treatment in CK18 Positive Patients

March 28, 2016 updated by: ShenFeng, Eastern Hepatobiliary Surgery Hospital

The Effect of Postoperative Adjuvant TACE Treatment in CK18 Positive Patients of Hepatocellular Carcinoma.

To evaluate and analyse the clinical effect and application value of postoperative adjuvant TACE treatment in patients with different expression levels of CK18 using randomized controlled study and provide evidence for the necessity of postoperative adjuvant TACE.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

320

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200438
        • Eastern hepatobilliary surgery hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

320 patients with HCC

Description

Inclusion Criteria:

  1. Via clinical diagnosis and confirm it is primary liver cancer
  2. Pathological evidence of HCC
  3. Estimate tumor can gain treatment of curing operation
  4. No evidence for extrahepatic metestasis
  5. liver function ：Child-Pugh A/B

Exclusion Criteria:

  1. reject to attend；
  2. impossible to come to our hospital for physical examination regularly.
  3. cancer epitome、seed focus、lymph node or distant metastasis
  4. Blood clotting function hindrance; 5, Patients with other diseases which may affect the treatment mentioned.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
CK18 positive
HCC patients with CK18 high expression levels in tumor tissue.
CK18 negative
HCC patients with CK18 high expression levels in tumor tissue.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to recurrence
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eastern Hepatobiliary Surgery Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ACTUAL)

June 1, 2015

Study Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

March 28, 2016

First Submitted That Met QC Criteria

March 28, 2016

First Posted (ESTIMATE)

March 31, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

March 31, 2016

Last Update Submitted That Met QC Criteria

March 28, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZD201206002-P1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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