TACE Combined With RFA/MV Treatment in Hepatocellular Carcinoma Beyond Milan Criterial (TACE+RFA)

August 15, 2018 updated by: Zheng-Gang Ren, Fudan University

Clinical Trial of Transcatheter Arterial Chemoembolization Combined With Radiofrequency/Microwave Ablation in Hepatocellular Carcinoma Beyond Milan Criterial

This study was designed to evaluate the effectiveness of radiofrequency /microwave ablation in patients with hepatocellular carcinoma beyond Milan Criteria.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to included 120 patients with intermediate stage hepatocellular carcinoma beyond Milan criteria .These patients were randomizedly allocated to TACE treatment group or TACE+RFA/MV .The treatment effectiveness, local tumor control and survival outcome between the two groups were compared.

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Phase 3

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, China, 200032
        • liver cancer institute ,Fudan University

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients diganosed with hepatocellualr carcinoma beyond Milan criteria
  • the presence of a single HCC tumor ≤7 cm in diameter, or multi-nodular HCC tumors (n ≤ 5) small than 7 cm in diameter;
  • Child-Pugh A or B
  • ECOG score 0-1;
  • prothrombin time ≤16 s;
  • white cell count ≥3,000/mm3, platelet count ≥40 x 109/L;Hb≥8.5 g/d; ALT/AST≤5×ULN;TB≤3mg/dl;alb≥2.8 g/dl ;Scr ≤2mg/dl

Exclusion Criteria:

  • expected survival time < 12 months before random assignment;
  • received anticancer surgery or procedure within one month before assignment;
  • concomitant use of any other anticancer therapy(except immunotherapy and herbal medicine ) ;
  • existence of portal of hepatic vein invation or extrahepatic metastases;existence of active infection ;
  • upper gastrointestinal hemorrhage within one month ; .other serious illness or medical condition.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TACE group
Transcatheter arterial chemoembolization
Device: Transcatheter arterial chemoembolization
Transcatheter arterial chemoembolization
Other Names:
  • TACE
Experimental: TACE+RFA/MV group
Transcatheter arterial chemoembolization and radiofrequency /microwave ablation
Device: Transcatheter arterial chemoembolization
Transcatheter arterial chemoembolization
Other Names:
  • TACE
Device: radiofrequency ablation/microwave ablation
radiofrequency ablation/microwave ablation
Other Names:
  • RFA/MW

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: up to 46 months
up to 46 months

Secondary Outcome Measures

Outcome Measure
Time Frame
objective response rate
Time Frame: up to 46 months
up to 46 months

Collaborators and Investigators

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

Sponsor

Fudan University

Investigators

  • Principal Investigator: zheng-gang Ren, doctor, Fudan University

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 (Actual)

June 1, 2013

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

August 8, 2018

First Submitted That Met QC Criteria

August 15, 2018

First Posted (Actual)

August 17, 2018

Study Record Updates

Last Update Posted (Actual)

August 17, 2018

Last Update Submitted That Met QC Criteria

August 15, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LC-TACE+RFA/MV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

no plan to make individual paticipant data available to other researchers

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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