Resection Versus Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma With Solitary Huge Tumor

April 12, 2018 updated by: Xiaoping Chen, Huazhong University of Science and Technology

Resection Versus Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma With Solitary Huge Tumor: a Randomized Controlled Trial

This clinical trial aims to compare hepatectomy with Transarterial Chemoembolization (TACE) for Hepatic Cellular Cancer With Solitary Huge Tumor (≥5cm). All patients will be divided into two group.One group will receive hepatic resection, while an another equivalent group patients will be treated with Transarterial Chemoembolization.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Hepatocellular carcinoma (HCC) is the most common primary malignant tumor of the liver.For Barcelona Clinic Liver Cancer (BCLC) stage B patients，especially those with Solitary Huge Tumor (≥5cm) ，the better therapy between hepatic resection and transarterial chemoembolization remains controversial despite extensive studies。 From now on, we prospectively collected patients with solitary huge HCC who received hepatectomy or TACE. Of the 200 patients，100 patients were surgically treated and the others underwent TACE。After the treatment, patients received routine follow-up with physical examination, serum α-fetoprotein (AFP) level and ultrasonography at 3-month intervals for the first year and then every 6 months.The end of follow-up was determined as either the time of last follow-up (July 2019) or death. The overall survival，including 1, 2 and 3-year overall survival rates，will be analyse. All data are collected prospectively.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

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
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Hepatic surgery center, Tong ji Hospital
        • Contact:

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

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of Hepatic cellular Carcinoma.
  • Patients with Solitary Huge Tumor (≥5cm）of Hepatic cellular Carcinoma (HCC) detected by Serum Alpha Fetoprotein (AFP) and CT or MRI.
  • Patients without Hepatic vein or bile duct invasion and extrahepatic metastasis.
  • Patients without surgical contraindication.
  • Patients with Child A or B liver function and indocyanine green retention rate at 15min (ICGR15) < 10% before treatment.
  • Laboratory examination: haemoglobin (Hb)>100g/L, white blood cell (WBC) > 3000/mL, blood platelet counts (PLT) > 8×10*10/L before treatment.
  • Patients without severe esophagogastric varices before treatment.
  • Patients with HBV，HBV DNA≤100, 000 copy/mL.
  • All of the patients has written consent for this research.

Exclusion Criteria:

  • Patients with multiple tumors or vascular or bile duct invasion or extrahepatic metastasis.
  • Patients with surgical contraindication.
  • Patients with Child C grade liver function before treatment.
  • Patients with other malignancy.
  • .Patients treated with hepatic resection or TACE before this treatment.
  • Patients with severe esophagogastric varices or refractory ascites or coagulation dysfunction before treatment.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Hepatic resection
Indications for Hepatic resection were the presence of appropriate residual liver volume determined by volumetric computed tomography and lack of hepatic encephalopathy.
Procedure: hepatic resection
The aim of this intervention is to reach curative resection.
Other Names:
  • control
Experimental: Transarterial Chemoembolization(TACE)
Transarterial Chemoembolization is performed in less than one week after clinical diagnosis.
Procedure: TACE
The aim of this intervention is one of the palliative treatment.
Other Names:
  • trial

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-year overall survival
Time Frame: 3 years
Overall survival rate will be evaluated at 3 years after treatment
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1-year overall survival
Time Frame: 1 years
Overall survival rate will be evaluated at 1 year after treatment
1 years
2-year overall survival
Time Frame: 2 years
Overall survival rate will be evaluated at 2 years after treatment
2 years
Recurrence rates
Time Frame: 3 years
any recurrence detected by CT, MRI and laboratory examination
3 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
mortality
Time Frame: 30 days
death within 30 days after surgery
30 days

Collaborators and Investigators

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

Sponsor

Huazhong University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

July 5, 2016

Primary Completion (Anticipated)

July 5, 2018

Study Completion (Anticipated)

July 5, 2019

Study Registration Dates

First Submitted

June 14, 2017

First Submitted That Met QC Criteria

June 16, 2017

First Posted (Actual)

June 19, 2017

Study Record Updates

Last Update Posted (Actual)

April 13, 2018

Last Update Submitted That Met QC Criteria

April 12, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • chenxp008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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