Evaluation the Treatment Outcome for RFA in Patients With BCLC Stage B HCC in Comparison With TACE

July 25, 2020 updated by: Zheng-Gang Ren, Fudan University

Liver Cancer Institiute ,Fudan University

Evaluation the Treatment Outcome for RFA in Patients With BCLC Stage B HCC in Comparison With TACE

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The investigators conduct this clinical trial to evaluate the treatment outcome of RFA in HCC patients with tumor smaller than 7cm and tumor number less than five ,in comparison with TACE treatment.The primary outcome is overall survival.The secondary outcome is objective response rate.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 2
  • 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 Contact

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Zhongshan Hospital Fudan University
        • Contact:
        • Principal Investigator:
          • zhenggang Ren, professor

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:

  • age 18 to 75 years ;
  • HCC confirmed by pathological or clinical diagnosis according to the American Association for the Study of Liver Diseases criteria ;
  • solitary HCC less than 7cm in diameter or multiple HCC lesions less 5
  • the absence of portal/hepatic vein invasion, lymph node involvement and extrahepatic metastases;
  • lesions visible on ultrasound with a safe path between the lesion and skin;
  • an Eastern Cooperative Oncology Group performance status of 0-1;
  • Child-Pugh class A or B cirrhosis.

The exclusion criteria :

  • received any other previous treatment for HCC;
  • severe coagulation disorders;
  • evidence of hepatic decompensation including hepatic encephalopathy, ascites as well as esophageal or gastric variceal bleeding;
  • presence of serious medical comorbidities, including serious dysfunction of the heart or kidney ;
  • currently had other malignancies in addition to HCC.

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
Experimental: RFA group
Patients in RFA group will accept RFA treatment
Device: radiotherapy ablation
We using Cool Tip system or RITA system to perform RFA
Active Comparator: TACE group
Patients in TACE group will accept TACE treatment
Device: transarterial chemoembolization(TACE)
TACE treatment is a first line treatment for BCLC stage B HCC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: up to 60 months
up to 60 months

Secondary Outcome Measures

Outcome Measure
Time Frame
objective response rate
Time Frame: up to 60 months
up to 60 months

Collaborators and Investigators

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

Sponsor

Fudan University

Investigators

  • Principal Investigator: Zhenggang 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)

September 3, 2019

Primary Completion (Anticipated)

August 1, 2022

Study Completion (Anticipated)

August 1, 2022

Study Registration Dates

First Submitted

August 8, 2018

First Submitted That Met QC Criteria

August 20, 2018

First Posted (Actual)

August 22, 2018

Study Record Updates

Last Update Posted (Actual)

July 28, 2020

Last Update Submitted That Met QC Criteria

July 25, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LC-RFA vs.TACE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to make IPDavailable to other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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