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Comparison of Treatment of Recurrent HCC With Repeat Hepatectomy,and TACE With AFP Conversion (HCCTACEAFP)

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ClinicalTrials.gov Identifier: NCT02728219
Recruitment Status : Completed
First Posted : April 5, 2016
Last Update Posted : April 5, 2016
Sponsor:
Information provided by (Responsible Party):
ShenFeng, Eastern Hepatobiliary Surgery Hospital

Brief Summary:
The purpose of this study is to compare the treatment of recurrent hepatocellular carcinoma with repeat hepatectomy,and transcatheter arterial chemoembolization (TACE) with AFP conversion.

Condition or disease Intervention/treatment Phase
Recurrent Hepatocellular Carcinoma Procedure: TACE Procedure: Hepatectomy Not Applicable

Detailed Description:

Though many HCC patients have been benefited from hepatectomy treatment, still the high recurrence rate after the hepatectomy led to limited effectiveness.

This is the first study in same case system on comparison of effectiveness among repeat hepatectomy, and TACE with AFP conversion.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Trial Comparing Treatment of Recurrent HCC With Repeat Hepatectomy,and Transcatheter Arterial Chemoembolization (TACE) With AFP Conversion
Study Start Date : May 2012
Actual Primary Completion Date : November 2014
Actual Study Completion Date : May 2015

Arm Intervention/treatment
Experimental: hepatectomy
Comparison of Treatment of recurrent hepatocellular carcinoma with repeat hepatectomy,and transcatheter arterial chemoembolization (TACE) with AFP conversion
Procedure: TACE
In this study we prospectively select some early diagnosed recurrent HCC patients after radical resection with AFP conversion, then they will be treated with transcatheter arterial chemoembolization (TACE)
Other Name: transcatheter arterial chemoembolization

Active Comparator: TACE Procedure: Hepatectomy
Repeat Hepatectomy after postoperation recurrence




Primary Outcome Measures :
  1. overall survival [ Time Frame: 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. via clinical diagnosis and confirm it is early recurrent liver cancer with AFP conversion, and not accept any anticancer treatment.
  2. age:18-70years
  3. better liver function (Child-Pugh,class A or 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. serious heart、lung、kidney disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02728219


Locations
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China, Shanghai
Eastern hepatobilliary surgery hospital
Shanghai, Shanghai, China, 200438
Sponsors and Collaborators
Eastern Hepatobiliary Surgery Hospital
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Responsible Party: ShenFeng, vice president of the Eastern Hepatobiliary Surgery Hospotal, Eastern Hepatobiliary Surgery Hospital
ClinicalTrials.gov Identifier: NCT02728219    
Other Study ID Numbers: 2012ZX10002016007002
First Posted: April 5, 2016    Key Record Dates
Last Update Posted: April 5, 2016
Last Verified: March 2016
Keywords provided by ShenFeng, Eastern Hepatobiliary Surgery Hospital:
Recurrent Hepatocellular Carcinoma
transcatheter arterial chemoembolization
AFP conversion
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases