The Efficacy of Hepatectomy or TILA-TACE in Patients With Resectable Hepatocellular Carcinoma

October 15, 2017 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

A Randomized Controlled Trial of the Efficacy of Hepatectomy or TILA-TACE in Patients With Resectable Hepatocellular Carcinoma

Hepatocellular carcinoma (HCC) is one of the most common cancers in the world with major occurrences in eastern Asian countries such as China. HCC is the third leading cause of cancer-related deaths in the world. There are multiple treatment options for liver cancer including surgery, transcatheter arterial chemoembolization (TACE), liver transplantation, absolute ethanol injection, radiation therapy, and biological therapy. Surgery is the primary radical treatment measure for HCC, but its indication is narrow and is only suitable for certain group of patients. Another common treatment for liver cancer, TACE, can not only block tumor blood supply, control tumor growth, or even cause necrosis and result in tumor shrinkage, it can also deliver target chemotherapy drugs to the tumor tissue. However, there are still some controversies on the efficacy of TACE treatment. Therefore in this study, we will conduct a randomized comparison study of the efficacy of surgical resection and TILA-TACE treatment.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The Barcelona Clinic Liver Cancer staging system (BCLC) is one of the more recognized staging criteria and has been recommended by the European Association for the Study of Liver and the American Association for the Study of Liver Diseases. BCLC staging is based on patients' general condition, tumor condition, and liver function to identify the best treatment option and predict prognosis using evidence-based medicine. Surgical excision is recommended for BCLC stage 0, liver transplantation or radiofrequency ablation is recommended for BCLC stage A, and TACE treatment is recommended for BCLC stage B.

However, there are still some controversies on the efficacy of TACE treatment. In recent years, development of technologies has led to improved methods including targeting-intratumoral-lactic-acidosis TACE (TILA-TACE). Early clinical practice has confirmed that compared with TACE, TILA-TACE has a relatively high response rate and efficiency. In clinical practice, the current standard treatments for patients with surgically resectable HCC are controversial and there is no recommendation in the guidelines.

This study is designed to evaluate and compare the therapeutic efficacies of surgical resection and TILA-TACE treatment in patients with resectable HCC.

Study Type

Interventional

Enrollment (Anticipated)

230

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
    • Zhejiang
      • Hanzhou, Zhejiang, China, 310009
        • The Second Affiliated Hospital Zhejiang University School of Medicine

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:

  1. Ages 18-75 with no gender, ethnicity, religion, or geographical restrictions.
  2. Diagnosed HCC patient.
  3. The following criteria will be used for the evaluation of tumor resectability and adequate remaining liver volume: ≥ 30% remaining liver volume/total liver volume for non-hepatitis patients; ≥ 40% remaining liver volume/total liver volume for hepatitis patients.
  4. Imaging examination with no cancer embolus above the secondary branch of the portal vein.
  5. New lesions found five years after liver cancer treatment.
  6. Child-Pugh A or B grade liver function.
  7. No concurrent malignancies in other systems.
  8. Informed subjects who fully understand and willingly cooperate with the test program with signed relevant documents.

Exclusion Criteria:

  1. Suffer from other malignancies.
  2. Have received any other liver cancer treatments.
  3. Pathological diagnosis as non-HCC.
  4. Experience large blood vessel invasion, distant metastases, or unresectable liver cancer.
  5. One or more organ failures.
  6. Child-Pugh C grade liver function.
  7. Incomplete surgical resection or TILA-TACE.

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Surgery group
We will completely resection of the visible tumor and made the resection margin negative. We will use regular/irregular resection of the liver tumor tissue, hemihepatectomy or extended hepatectomy.
Experimental: TILA-TACE group
After femoral artery catheterization, 5-Fr angiography catheters will be used for complete radiography of the celiac artery, the hepatic artery proper, left and right hepatic arteries and their branches, and 2.8-Fr micro-catheters will be used for complete radiography of the tumor's nutrient arteries. Lipiodol-epirubicin emulsions and 5% sodium bicarbonate injection solutions will be used for perfusion of chemotherapy drugs. Different sizes of embolic microspheres will be used alternatively for chemoembolization.
Procedure: TILA-TACE
After femoral artery catheterization, 5-Fr angiography catheters will be used for complete radiography of the celiac artery, the hepatic artery proper, left and right hepatic arteries and their branches, and 2.8-Fr micro-catheters will be used for complete radiography of the tumor's nutrient arteries. Lipiodol-epirubicin emulsions and 5% sodium bicarbonate injection solutions will be used for perfusion of chemotherapy drugs. Different sizes of embolic microspheres will be used alternatively for chemoembolization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
disease-progression-free period
Time Frame: This will be the time period from the beginning of treatment to the time that disease progression has been observed (up to 120 months).
This will be the time period from the beginning of treatment to the time that disease progression has been observed.
This will be the time period from the beginning of treatment to the time that disease progression has been observed (up to 120 months).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival period
Time Frame: from the beginning of the treatment, until the death of the patient or the end of the study period (up to 100 months).
from the beginning of the treatment, the follow-up, until the death of the patient or the end of the study period, as well as the 1-year, 3-year, and 5-year survival rates.
from the beginning of the treatment, until the death of the patient or the end of the study period (up to 100 months).

Collaborators and Investigators

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

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

  • Study Director: Jiang-tao Li, MD, Second Affiliated Hospital, School of Medicine, Zhejiang University

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 (Anticipated)

November 1, 2017

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

October 8, 2017

First Submitted That Met QC Criteria

October 15, 2017

First Posted (Actual)

October 19, 2017

Study Record Updates

Last Update Posted (Actual)

October 19, 2017

Last Update Submitted That Met QC Criteria

October 15, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAHZhejiangU-2017-071

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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